MPS3 ND CONSOLE
Received May 18, 2026 · Event occurred Apr 20, 2026
Report 1649914-2026-00011 · MDR key 25203990
Device
Generic name
Cardiopulmonary Bypass Heat Exchanger,
Manufacturer
Quest Medical, Inc.Model number
5301000NDProduct problems
- Failure to Deliver
- Output Problem
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION IS COMPLETED.
Description of Event or Problem
THE REPORT STATES UNIT (B)(6) DISPLAYED AN ERROR CODE. THERE WAS NO OBSTRUCTION IN THE K+ DELIVERY LINE. THE SYSTEM KEPT TURNING OFF THE K+ DELIVERY AND THE "CONFIRM/RECHECK YELLOW ERROR SCREEN" KEPT POPPING UP. WHILE WE HIT RECHECK AND DELIVERY STARTED, IT THEN STOPPED AGAIN. THE SEQUENCE WAS REPEATED SEVERAL TIMES. UPDATE: YES, THERE WAS DELAY IN ARRESTING THE HEART. WE HAD TO REMOVE AND REAPPLY THE CROSS-CLAMP WHILE WAITING TO ADDRESS THE ISSUE. APPROXIMATE DELAY TIME WAS 5 MINUTES. THE HEART WAS SLUGGISH UPON CROSS-CLAMP REMOVAL, AT THE END OF THE PROCEDURE. MEDICATIONS WERE NEEDED TO SUPPORT THE HEART FUNCTION. NO ASSIST DEVICE WAS NEEDED.