Medical recall. Ping Jeorg

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Poxy snot. Here is another one:

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Date: Mon, 28 May 2012 11:12:54 -0400 =46rom: Monty Solomon 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)

??-)

To err is human.

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.

--
My liberal friends think I'm a conservative kook.
My conservative friends think I'm a liberal kook.
Why am I not happy that they have found common ground?

Tim Wescott, Communications, Control, Circuits & Software
http://www.wescottdesign.com

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.

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.

--
Regards,
Martin Brown

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 ...

--
Regards, Joerg

http://www.analogconsultants.com/

Software

Switching

Stimulator

Unit,

software

electrode

cortical

Both

tissue.

leading

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Food

as

an

designed

one

dosing

ion-based

Single

(Abacus

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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 c*ck-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).

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...

--
Regards,
Martin Brown