Medtronic Inc. has issued a Class I recall for the SynchroMed II Programmable Pump, SynchroMed EL Infusion System and Refill Kits. These defective medical devices have been linked to 8 deaths.
The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient’s body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception of Medtronic MiniMed Infusion Pumps.
According to the Medtronic recall notice, inadvertent injections during refill procedures known as pocket fills can cause patients to get too much or too little of a medicine administered by the infusion pumps. In at least some of the problem cases, the drugs were injected directly into the patients all at once rather than gradually through the pump. Pocket fills may occur because the physician relies heavily on tactile feedback to determine if the needle is correctly positioned in the pump reservoir during drug refill, Medtronic said.
From May 1996 through September 2010, eight deaths and 270 events requiring medical intervention (serious or life-threatening injury) have been reported related to the occurrence of pocket fills. The reported rate of occurrence per refill opportunity is as high as 1 per 10,000 refills, Medtronic said.
After an in-depth review of the causes of pocket fills, Medtronic determined that pump labeling could be updated to provide additional information to clinicians on using visual and tactile assessments to attain and maintain the appropriate location of the needle throughout the refill procedure. Medtronic is not retrieving the product from the field or recommending the removal of the product in association with its communication to physicians.
On January 14, 2011, Medtronic sent an “Urgent: Medical Device Correction” letter to healthcare professionals reminding them of the potential for pocket fills to occur during the SynchroMed II or SynchroMed EL infusion pump refill procedure. Healthcare professionals were reminded that during the pump refill procedure, it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the reservoir. The communication included other recommendations for avoiding pocket fills, such as steps that can be taken to assess needle position throughout the procedure and for managing patients.
The SynchroMed pump manuals and refill kit manuals currently include warnings related to the potential for improper injection. Medtronic is currently updating the labeling for the SynchroMed II and EL pumps and associated refill kits with the information and patient management recommendations from the January 2011 communication.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of a defective medical device will cause serious adverse health consequences or death.
According to a report in the Minneapolis Star Tribune, the U.S. Food & Drug Administration (FDA) warned Medtronic in 2009 for failing to correctly report and fix problems with its SynchroMed pumps. The company said at the time that there hadn’t been any deaths tied to the devices.