Recalls, warnings, safety alerts
A warning that St. Jude Medical's radio frequency-enabled implantable cardiac devices Merlin@home transmitter have potential cybersecurity vulnerabilities. If exploited, such vulnerabilities could allow an unauthorized user to remotely access a patient's device by altering the transmitter. Programming commands could then be modified, resulting in rapid battery depletion and/or inappropriate pacing or shocks. The manufacturer has applied a software patch to the transmitters, and the FDA has ensured that the patch reduces the risk of exploitation and subsequent patient harm. There have been no related reports of patient harm.
A safety communication about serious adverse events, including patient injury and death, associated with implantable infusion pumps and magnetic resonance imaging (MRI). The reports describe dosing inaccuracies (e.g., over- or under-infusion, unintended bolus) and mechanical problems with the pump (e.g., motor stall, pump not restarting after MRI). The only implantable infusion pumps that may be used safely near MRIs are labeled as MR Conditional, and specific instructions vary by make and model. The FDA is working with manufacturers to update MRI safety information in their device labeling to ensure safe use.
A recall of Medrad Intego PET Infusion System source administration sets because they may produce a particulate matter in the medicine vials. The system controls and delivers medications during nuclear medicine procedures. Affected administration sets were distributed between Oct. 9, 2008, and Oct. 11, 2016.
A recall of one lot of vancomycin hydrochloride for injection to the hospital/retail level due to a confirmed customer report of particulate matter identified in one vial. There have been no reports of associated adverse events in this lot, which was distributed from August through September 2016.
Removal of Fuji's legacy 250/450 duodenoscope models from clinical use based on the limited number that are currently in use. The manufacturer will replace these models with its ED-530XT duodenoscope model and any necessary accessories (e.g., brushes) at no cost. Validated manual reprocessing procedures for the ED-530XT model, outlined in December 2015, remain the same.
An updated safety communication about Pentax's ED-3490TK video duodenoscope. The original alert, issued in February 2016, informed users that a design issue with the model could increase the risk of patient infection. Since then, the manufacturer has reported that cracks and gaps in the adhesive that seals the device's distal cap to its distal tip can occur, potentially leading to microbial and fluid ingress. These areas can be difficult to appropriately clean and disinfect. The validated manual processing procedures issued last year by the manufacturer remain the same and should supplant the original instructions. The FDA recommends that facilities train staff on the updated procedures and implement them, if they have not already done so.
A voluntary field action for the Lifepak 1000 defibrillator in response to 34 reports of the device shutting down unexpectedly during patient treatment. The issue is due to an intermittent connection between the device's battery and electrical contacts. At least eight related adverse events have been reported. Affected customers are advised to immediately remove and reinstall the battery from their devices and implement a weekly schedule of battery removal and reinstallation. The company will conduct a hardware device correction for all affected devices.
A class I recall of 2,906 Standard Offset Cup Impactors with POM-C handles because of inadequate sterilization. The reusable handheld devices, which are used during hip joint-replacement surgeries to implant prosthetic cups in the acetabulum, must be sterilized prior to surgical use but failed sterility testing when sterilized in a dedicated instrument case. The manufacturer has developed new sterilization recommendations that meet acceptable sterility assurance levels. The device must be individually wrapped during sterilization processing. Recalled products were distributed from July 30, 2004, to Dec. 22, 2015.
Plecanatide (Trulance) to treat adult patients with chronic idiopathic constipation. The oral medication is taken once per day and works in the upper gastrointestinal tract to stimulate secretion of intestinal fluid, supporting regular bowel function. Safety and efficacy were demonstrated in two 12-week, placebo-controlled trials of 1,775 participants diagnosed with constipation. Those who received the medication were more likely than those who received placebo to experience improvements in stool frequency, consistency, straining, and the frequency of complete spontaneous bowel movements. The most common side effect was diarrhea, and patients should stop taking the medication and contact their clinician if severe diarrhea occurs. The medication should not be used in patients under age 18 years or those with known or suspected mechanical gastrointestinal obstruction.