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The Food and Drug Adminstration announced a recall of the the power packs used in D-TRON Insulin pumps. The pumps, used for mechanical supplementation of insulin in patients (usually diabetics) apparently contain a redesigned battery, which has caused problems with the pump.

It is unclear whether the battery was redesigned and manufatured by the pump manufacturer itself or whether a third part was involved. However, it is somewhat clear that the insulin pump uses a battery to operate and that the pump’s design provides for some type of audible low battery warning indicator.

The battery redesign, according to the recall report, failed to provide the pump with sufficient time for it to detect a decrease in its power supply. The failure of the pump to detect a decrease in the power supply would result in a loss of the low battery warning indicator and for the battery to discharge without clear warning. A patient who relies on the pump for insulin supplementation may not realize that the pump has stopped pumping insulin. Insufficient insulin supply in diabetic patients may cause nausea, vomiting, diabetic ketacidosis, coma and death.

Simply because someone has been injured by a recalled product does not mean that the manufacturer is liable. In most jurisdictions, a manufacturer is only required to address dangers about which it knew or, in the excercise of reasonable prudence, should have known. If you would like to know more about potential liability related to the D-TRON Insulin pumps, please contact me through the website: Thanks for reading.

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