Medical recall. Ping Jeorg

[josephkk]

Hey Jeorg,

How do you think this happened?

Cribbed:
+++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400
From: Monty Solomon <[email protected]>
Subject: Class 1 Recall: Nicolet, Software Malfunction and Short Circuit

CareFusion Cortical Stimulator Control Unit:
Class 1 Recall - Software Malfunction and Short Circuit

Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching
Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator
License
U.S. Food and Drug Administration [Posted 02/23/2012]

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit,
Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne
Software
with Cortical Stimulator License for two reasons: the device's software
incorrectly indicates stimulation is delivered to a different electrode
than
the one selected and a short circuit may develop between the cortical
stimulator control unit and the stimulus switching unit amplifier. Both
of
these issues may result in the surgeon resecting the wrong brain tissue.
The
surgeon may also fail to resect pathological tissue, potentially leading
to
continued pathologic processes and the need for re-operations. ...

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm292975.htm


=========================================

?-)

 

[josephkk]

Hey Jeorg,

How do you think this happened?

Cribbed:
+++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400
From: Monty Solomon <[email protected]>
Subject: Class 1 Recall: Nicolet, Software Malfunction and Short Circuit

CareFusion Cortical Stimulator Control Unit:
Class 1 Recall - Software Malfunction and Short Circuit

Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching
Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator
License
U.S. Food and Drug Administration [Posted 02/23/2012]

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit,
Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne
Software
with Cortical Stimulator License for two reasons: the device's software
incorrectly indicates stimulation is delivered to a different electrode
than
the one selected and a short circuit may develop between the cortical
stimulator control unit and the stimulus switching unit amplifier. Both
of
these issues may result in the surgeon resecting the wrong brain tissue.
The
surgeon may also fail to resect pathological tissue, potentially leading
to
continued pathologic processes and the need for re-operations. ...

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm292975.htm


=========================================

?-)

Poxy snot. Here is another one:

++++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400
From: Monty Solomon <[email protected]>
Subject: Class I Recall: Baxa Software, Potential Dosing Errors

Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation
Software: Class I Recall - Potential Dosing Errors [PGN-ed]
U.S. Food and Drug Administration [Posted 05/25/2012]

AUDIENCE: Pharmacy, Risk Manager

ISSUE: A number of errors have been reported by Abacus software users as a
result of ordering salt based parenteral nutrition ingredients on an ion
based ordering template. Abacus TPN Calculation Software is designed and
intended to allow the ordering of electrolytes in only one of two ways: as
a
salt (such as calcium gluconate 10%) or as an elemental ion (such as
calcium). However, if a dosage is entered into the system based on one
method, when the template is configured for the other method, a dosing
error
can occur.

The problem associated with mix-ups related to salt-based or ion-based
ordering of electrolytes is not exclusive to calcium gluconate. ...

The Abacus TPN Calculation Software was manufactured and distributed from
August 7, 2006 through April 15, 2009. Affected catalog numbers include:

8300-0045: Abacus Calculator Only (Abacus CE)
8300-0046: Abacus Single Work Station (Abacus SE)
8300-0047: Abacus Multi-Work Station (Abacus ME)

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm305762.htm

===========================================

??-)

 

[Martin Brown]

Hey Jeorg,

How do you think this happened?

Cribbed:
+++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400 From: Monty Solomon
<[email protected]> Subject: Class 1 Recall: Nicolet, Software
Malfunction and Short Circuit

CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software
Malfunction and Short Circuit

Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching
Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator
License
U.S. Food and Drug Administration [Posted 02/23/2012]

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit,
Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne
Software
with Cortical Stimulator License for two reasons: the device's software
incorrectly indicates stimulation is delivered to a different electrode
than
the one selected and a short circuit may develop between the cortical
stimulator control unit and the stimulus switching unit amplifier. Both
of
these issues may result in the surgeon resecting the wrong brain tissue.
The
surgeon may also fail to resect pathological tissue, potentially leading
to
continued pathologic processes and the need for re-operations. ...

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm292975.htm


=========================================

?-)

Poxy snot. Here is another one:

++++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400 From: Monty Solomon
<[email protected]> Subject: Class I Recall: Baxa Software, Potential
Dosing Errors

Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation
Software: Class I Recall - Potential Dosing Errors [PGN-ed] U.S. Food
and Drug Administration [Posted 05/25/2012]

AUDIENCE: Pharmacy, Risk Manager

ISSUE: A number of errors have been reported by Abacus software users as
a result of ordering salt based parenteral nutrition ingredients on an
ion based ordering template. Abacus TPN Calculation Software is designed
and intended to allow the ordering of electrolytes in only one of two
ways: as a
salt (such as calcium gluconate 10%) or as an elemental ion (such as
calcium). However, if a dosage is entered into the system based on one
method, when the template is configured for the other method, a dosing
error
can occur.

The problem associated with mix-ups related to salt-based or ion-based
ordering of electrolytes is not exclusive to calcium gluconate. ...

The Abacus TPN Calculation Software was manufactured and distributed
from August 7, 2006 through April 15, 2009. Affected catalog numbers
include:

8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single
Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus
ME)

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm305762.htm

===========================================

??-)

To err is human.

But really screw things up requires a computer. It is *very* surprising
that this second one did not have regression testing to establish that
results matched expectations no matter what order the calculation was
done. It is inexcusable to have this sort of fault in modern software.

Someone done f**ked up, and someone else didn't catch it. That's the
nice thing about medical device regulations: all the screwups require
teamwork.

I suppose it depends a bit how bad the dosing error actually is. A few
percent either way isn't going to make much difference in most diets.

By comparison frying the wrong bit of brain to a crisp is very serious.

 

[Joerg]

Hey Jeorg,

How do you think this happened?

Cribbed:
+++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400
From: Monty Solomon <[email protected]>
Subject: Class 1 Recall: Nicolet, Software Malfunction and Short Circuit

CareFusion Cortical Stimulator Control Unit:
Class 1 Recall - Software Malfunction and Short Circuit

Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching
Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator
License
U.S. Food and Drug Administration [Posted 02/23/2012]

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit,
Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne
Software
with Cortical Stimulator License for two reasons: the device's software
incorrectly indicates stimulation is delivered to a different electrode
than
the one selected and a short circuit may develop between the cortical
stimulator control unit and the stimulus switching unit amplifier. Both
of
these issues may result in the surgeon resecting the wrong brain tissue.
The
surgeon may also fail to resect pathological tissue, potentially leading
to
continued pathologic processes and the need for re-operations. ...

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm292975.htm


=========================================

?-)

Poxy snot. Here is another one:

++++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400
From: Monty Solomon <[email protected]>
Subject: Class I Recall: Baxa Software, Potential Dosing Errors

Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation
Software: Class I Recall - Potential Dosing Errors [PGN-ed]
U.S. Food and Drug Administration [Posted 05/25/2012]

AUDIENCE: Pharmacy, Risk Manager

ISSUE: A number of errors have been reported by Abacus software users as a
result of ordering salt based parenteral nutrition ingredients on an ion
based ordering template. Abacus TPN Calculation Software is designed and
intended to allow the ordering of electrolytes in only one of two ways: as
a
salt (such as calcium gluconate 10%) or as an elemental ion (such as
calcium). However, if a dosage is entered into the system based on one
method, when the template is configured for the other method, a dosing
error
can occur.

The problem associated with mix-ups related to salt-based or ion-based
ordering of electrolytes is not exclusive to calcium gluconate. ...

The Abacus TPN Calculation Software was manufactured and distributed from
August 7, 2006 through April 15, 2009. Affected catalog numbers include:

8300-0045: Abacus Calculator Only (Abacus CE)
8300-0046: Abacus Single Work Station (Abacus SE)
8300-0047: Abacus Multi-Work Station (Abacus ME)

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm305762.htm

===========================================

As Tim said, it's usually caused by not being thorough enough in design
reviews. Also, many companies shy away from using external consultants
in those reviews yet that's exactly what they need to do. Because
internal guys, no matter how good they are, will often be less sensitive
to potential hazards since they are used to the way "it's always been
done". Just like a driver often won't notice a deterioration in the
brake system of his own car but the guy borrowing this car will.

More than once have I found serious show stoppers of the "Oh s..t!" kind
when reviewing designs. In the same way that when I drove a co-workers
Saab in Scotland I thought the brake pedal was unusually mushy. So I
told the owner. We looked at the reservoir ... pretty low. I touched the
floor mat ... all wet and had a soapy feel to it ...

 

[josephkk]

On Mon, 28 May 2012 17:56:27 -0700, josephkk


Hey Jeorg,

How do you think this happened?

Cribbed:
+++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400 From: Monty Solomon
<[email protected]> Subject: Class 1 Recall: Nicolet, Software
Malfunction and Short Circuit

CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software
Malfunction and Short Circuit

Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching
Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator
License
U.S. Food and Drug Administration [Posted 02/23/2012]

AUDIENCE: Neurology, Risk Managers

ISSUE: CareFusion is recalling Nicolet Cortical Stimulator Control Unit,
Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne
Software
with Cortical Stimulator License for two reasons: the device's software
incorrectly indicates stimulation is delivered to a different electrode
than
the one selected and a short circuit may develop between the cortical
stimulator control unit and the stimulus switching unit amplifier. Both
of
these issues may result in the surgeon resecting the wrong brain tissue.
The
surgeon may also fail to resect pathological tissue, potentially leading
to
continued pathologic processes and the need for re-operations. ...

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm292975.htm


=========================================

?-)

Poxy snot. Here is another one:

++++++++++++++++++++++++++++++++++++++++++


Date: Mon, 28 May 2012 11:12:54 -0400 From: Monty Solomon
<[email protected]> Subject: Class I Recall: Baxa Software, Potential
Dosing Errors

Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation
Software: Class I Recall - Potential Dosing Errors [PGN-ed] U.S. Food
and Drug Administration [Posted 05/25/2012]

AUDIENCE: Pharmacy, Risk Manager

ISSUE: A number of errors have been reported by Abacus software usersas
a result of ordering salt based parenteral nutrition ingredients on an
ion based ordering template. Abacus TPN Calculation Software is designed
and intended to allow the ordering of electrolytes in only one of two
ways: as a
salt (such as calcium gluconate 10%) or as an elemental ion (such as
calcium). However, if a dosage is entered into the system based on one
method, when the template is configured for the other method, a dosing
error
can occur.

The problem associated with mix-ups related to salt-based or ion-based
ordering of electrolytes is not exclusive to calcium gluconate. ...

The Abacus TPN Calculation Software was manufactured and distributed
from August 7, 2006 through April 15, 2009. Affected catalog numbers
include:

8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single
Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus
ME)

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm305762.htm

===========================================

??-)

To err is human.

But really screw things up requires a computer. It is *very* surprising
that this second one did not have regression testing to establish that
results matched expectations no matter what order the calculation was
done. It is inexcusable to have this sort of fault in modern software.

Someone done f**ked up, and someone else didn't catch it. That's the
nice thing about medical device regulations: all the screwups require
teamwork.

I suppose it depends a bit how bad the dosing error actually is. A few
percent either way isn't going to make much difference in most diets.

By comparison frying the wrong bit of brain to a crisp is very serious.

Unless i misread the information worse than usual, the Abacus TPS is used
for surgical guidance in brain surgery rather than radiotherapy. The
importance of NOT causing errors in sensitive surgeries is not to be
dismissed. Serious it is. Another user interface design error.

?-)

 

[Martin Brown]

Unless i misread the information worse than usual, the Abacus TPS is used
for surgical guidance in brain surgery rather than radiotherapy. The
importance of NOT causing errors in sensitive surgeries is not to be
dismissed. Serious it is. Another user interface design error.

?-)

Quite a lot of serious usability faults in big systems occur because the
people who have final say are too high up and the guys who will have to
work with the software are kept out of the specification loop. The
result is that something very obvious to the people who do it every day
is completely missing from the specification and the system as delivered
is completely unworkable. There then follows loads of expensive
cost-plus remedial work or abandonment. The UK government and MOD in
particular specialises in producing such mammouth cock-ups.

So far we have aircraft carriers with the aircraft respecified three
times every time with a huge increase in costs. Completely unflyable
Chinooks unfit for an airworthyness certificate and two dozen top
security experts killed as a result (they tried to blame the pilots).

http://en.wikipedia.org/wiki/1994_Scotland_RAF_Chinook_crash

Most practitioners believe software errors in the engine FADECs were the
root cause of the problem. Although the UK Chinooks are also completely
useless in cloudy weather or fog for similarly stupid specification
errors. Odd really the UK has a lot of clouds...