Recalls, recalls, recalls–FDA officials were busy working with manufacturers of dangerous medical devices last week to inform the public of potentially injurious medical products it has decided must be removed from market. Included in these FDA recalls were Baxter International’s Colleague Volumetric Infusion Pumps and Covidien’s tracheostomy tubes for children. Excluded from these FDA recalls was immediate action to protect patient safety and health.
Serious injury and death have been reported caused by Baxter International’s defective Colleague infusion pumps. These medical devices are used to deliver regular, controlled amounts of medication or other fluids to patients.
On January 23, 2009, the medical device manufacturer quietly issued letters to health care providers who owned its Baxter IV pumps warning of failure codes in the pumps could cause them to unexpectedly turn off and stop infusing, including critical medications necessary to the health of the patient. If a computer bug weren’t frightening enough, Baxter has also noted its Colleague pumps have a tendency to overheat, resulting in fire and smoke. If glitches or fires weren’t enough, Baxter’s Colleague Volumetric Infusion Pumps produced in the last ten years have also had been known to suddenly fail when running on battery power.
Last week (seven weeks since Baxter’s letter warning of their medical devices’ defects), FDA officials, having considered the evidence, decided that a Class I recall (the serious class of recalls reserved for drugs or medical devices that pose a likely threat to life or serious health risk) was in order.
In another bold move, the FDA publicized notice of another Class I recall on 21 lots of pediatric tracheostomy tubes, making public this threat to public safety a mere two months after it had concluded Covidien Ltd’s trach tubes as having “a reasonable probability that use of these products will cause serious injury or death.”
The recalled pediatric tracheostomy tubes (Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes, Covidien Inc manufactured 7/7/08 – 12/9/08) have a specific design flaw: ease of use. When you’re in the middle of surgery trying to suck fluid out of a kid’s throat or lungs, it’s nice when Part A fits smoothly into Slot B. What is less fun, I assume, is losing precious moments in surgery having to remove and replace a defective product from the throat of a child when defective medical Part A doesn’t fit in Slot B. And that’s the issue that the FDA took three months to decide to let the public know.
Surgeons using Covidien’s recalled pediatric tracheostomy tubes complained that its obturator (the device used to place the trach tube into the windpipe) and its catheter suction tube (inserted through the tracheostomy tube to allow the removal fluids in the lungs and throat) were causing dangerous surgical conditions. The obturator wasn’t allowing the trach tube to pierce the windpipe, or, if the trach tube was in place, the tube to suck the problem from the child’s throat or lungs couldn’t slide into the trach tube’s opening to do its job.
Meanwhile, no word yet from the FDA on Welch Allyn’s recall of 14,054 defibrillators after 39 reported incidents, including 20 instances of electrical shock, 11 unexpected device shutdowns, and 2 fatalities. The defected Welch Allyn defibrillators involve AED 10 and MRL JumpStart external defibrillators manufactured between 12/02 and 12/07.
If you or a loved one in Tennessee, Kentucky, or Georgia was injured by a malfunctioning defibrillator, defective infusion pump, or other dangerous medical device, my Nashville law offices would like to extend our legal help. Call (615) 353-0930 or fill out our medical device injury attorney form for a free initial consultation with a Tennessee defective medical device lawyer.