What a Serious Covidien Recall Should Teach You

Covidien recently announced a defibrillator electrodes recall, but the Class I-level recall has nothing to do with the mechanical functioning of the electrodes themselves.

Rather, the case is a tragic example of how devices are not always used the way the designers intend them to be used. That is why it is always important to never underestimate the potential for human error with devices, and never use detectability to estimate risk to end-users.

The recalled electrodes--more than 600,000 Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes--do not connect with Philips FR3 or FRx AED units. But health providers and other users were apparently unaware and connected them anyway, even though it was Philips brand electrodes that were specified in the equipment manual.

Covidien says it has received two instances where customers attempted to use a Covidien electrode with a Philips FR3 AED unit, with the mismatch potentially contributing to the death of one patient.

Philips had a fail-safe with the FRx AED units, which require pre-connection of pads and continuously issue an alarm chirp if incompatible pads are used. The FR3, though, does not require pre-connection, and the user will not discover the compatibility issue until the AED is used.

Covidien says it alerted customers to the this issue by letter on September 18, and has revised labeling to clarify that use of these electrodes is incompatible with Philips FR3 and FRx AED units.

The Field Safety Alert requests that customers review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.

More information about the recall is on the FDA's website.

Earlier this year, Thoratec Corp. issued an urgent safety advisory over four patient deaths related to its HeartMate II left ventricular assist device. No products need to be returned because the deaths and serious injuries were not the result of device failure, but rather patients and caregivers who were unable to understand instructions.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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