Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its MiniMed Implantable Pump [Model Number/ CFN: MMT-2007D; Lot Number: 31332, 31359 and 31360].
The manufacturer has initiated Field Corrective Action about MiniMed Implantable Pump Endotoxin Issue. Routine testing is performed on samples of the MiniMed Implantable Pump as part of the manufacturing process to ensure the level of endotoxins present inside the insulin chamber of the device meets an approved limit. Endotoxins are remnants of gram-negative bacteria that may remain after the device is sterilized and are non-toxic when present below a pre-specified level.
The manufacturer received an endotoxin-related test result in their manufacturing process that did not meet their quality specifications. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis, potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death. Considering the immediate nature of a pyrogenic response, no incremental risk is expected for patients with implanted devices.
According to the manufacturer, this issue affects MiniMed Implantable Pumps produced since 21 May 2019. As of 15 April 2020, there have been no reported complaints from its customers for affected pumps as a result of the issue. There are no recommended actions required for implanted pumps.
Affected customers are required to take the following actions:
Product replacement is on-going.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 May 2020