CENTRIMAG BLOOD PUMP
Received Jun 11, 2026 · Event occurred May 12, 2026
Report 3003306248-2026-00221 · MDR key 25476667
Device
Generic name
Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Manufacturer
Thoratec CorporationModel number
102953Catalog number
102953
Product problems
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE A S3 "EMO" PUMP ALARM, WHICH OCCURRED WITH A STRONG CHEMICAL, ELECTRICAL BURN ODOR IN THE ROOM. THE FLOWS IN RPMS NEVER CHANGED. THE SITE LOOKED UP THE ALARM AND IT INDICATED POTENTIAL PUMP FAILURE. THE SITE REPLACED THE MOTOR AND THE CONSOLE WITH A NEW ONE. THE ALARMS CLEARED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PUMP NEVER STOPPED. THEY JUST CHANGED IT OUT FOR PRECAUTIONARY PURPOSES. THE PUMP WAS RAN IN THEIR STOREROOM FOR 48 HOURS WITH NO PROBLEMS. THEY PLANNED TO RETURN THE CONSOLE AND THE MOTOR TO ABBOTT FOR EVALUATION.
Additional Manufacturer Narrative
SECTION A: PATIENT INFORMATION WAS NOT YET PROVIDED. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.