Quest Medical Voluntarily Recalls Models of Some Blood Pumps Used in Bypass Surgery

Quest Medical has issued a nationwide voluntary recall of some models and lots of its Myocardial Protection System (MPS) Delivery Sets after receiving reports of possible seal failure that could result in blood loss for patients during on-pump or off-pump cardiac surgery. The delivery sets are used in conjunction with the MPS console, which is not affected by the recall.

The FDA posted a release from the company on October 28, 2015. In the release, Quest said they have received 20 complaints about the alleged seal failure, which they say has been linked to 16 instances of patient blood loss during surgery. The seal failure is believed to be along the blood source channel of the main pump cassette, and it can result in blood loss from the bypass circuit and interruption of delivery of cardioplegia solution.

There have been no reports of patient injuries as a result of the alleged issue to date. Quest has reported these events via the FDA Medwatch program and is notifying distributors and customers by certified letter/return receipt, as well as arranging for return and replacement of all recalled products.

The recall affects only:

• MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing (model 5001102)
• MPS Delivery Set with 6 ft. delivery tubing (model 5001102-AS)
• MPS Low Volume Delivery Set (model 7001102)

Quest says the recalled products were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015. The affected product lot information can be identified by product labeling on shipper and individual sterile trays.

Detailed information about the affected lots can be found at  http://www.fda.gov/Safety/Recalls/ucm470146.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. 

CORRECTION: An earlier version of this story mistakenly identified the manufacturer as Quest Diagnostics.