MPS3 ND CONSOLE
Received Jun 26, 2026 · Event occurred Jun 1, 2026
Report 1649914-2026-00012 · MDR key 25635275
Device
Generic name
Cardiopulmonary Bypass Heat Exchanger,
Manufacturer
Quest Medical, Inc.Model number
5301000NDProduct problems
- Electrical /Electronic Property Problem
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE REPORT STATED THAT AFTER APPROXIMATELY 150ML OF INDUCTION DOSE DELIVERY, THE CONSOLE PRESENTED AN ALARM MESSAGE REQUIRING A MANUAL RESTART OF THE CONSOLE SYSTEM. DURING THE SYSTEM RESTART THE PATIENT FIBRILLATED.
Additional Manufacturer Narrative
A COMPLAINT WAS RECEIVED AND REPORTED BY THE CLINICIAN (B)(4) QUEST) REGARDING USE OF PRODUCT MPS3ND (SERIAL NO. (B)(6)) AT (B)(6). DURING THE RESTART INTERVAL, THERAPY WAS INTERRUPTED AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. FOLLOWING COMPLETION OF THE REBOOT, THE CONSOLE RESUMED OPERATION AND FUNCTIONED AS DESIGNED. COMPANY TECHNICIAN DANA OWENS WAS PRESENT DURING THE EVENT AND REPORTED NO OBSERVED USER ERROR OR MISUSE OF THE DEVICE. THE SURGEON HAS REQUESTED REPLACEMENT OF THE DEVICE, NOTING THAT THIS WAS THE FIRST TIME THE PUMP WAS UTILIZED ON A PATIENT. THE DEVICE IS BEING EVALUATED. FURTHER INVESTIGATION RESULTS WILL BE PROVIDED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.