Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued an alert concerning Myocardial Protection System (MPS) Delivery Sets, manufacturer by Quest Medical Incorporation. The products have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.

The affected devices are shown below:

A) MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing

• Model number: 5001102
• Lot number: 0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04 0493675U04, 0493685U07, 0494465U07, 0494475U09, 0494855G01, 0495215U11 0495225U11, 0495505G02, 0495515G02, 0496535G08, 0496875G08, 0496885G08, 0497245S02

B) MPS Delivery Set with 6 ft. delivery tubing

• Model number: 5001102-AS
• Lot number: 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02

C) MPS Low Volume Delivery Set

• Model number: 7001102
• Lot number: 0492765E07

The manufacturer has received twenty complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. Nonetheless, there have been no reports of patient injuries as a result of the alleged issue to date.

The manufacturer recommends that consumers should cease to use the affected lots of the MPS Delivery Sets while product recall is on-going

If you are in possession of the affected products, please contact your supplier for necessary actions.

For details, please refer to the FDA websites:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm470194.htm
http://www.fda.gov/Safety/Recalls/ucm470146.htm

Posted on 30 October 2015