HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000002
- Event Type
- Malfunction
- Date Received
- January 7, 2025
- Date of Event
- December 24, 2024
- Report Date
- January 21, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿COM ERROR¿ WAS DISPLAYED ON THE ROTFLOW CONSOLE DURING USE. THE DEVICE WAS SHUT DOWN AND THEN RESTARTED WHICH DID NOT SOLVE THE PROBLEM. THE CUSTOMER IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE A REPORT IS REQUIRED. THE PATIENT DATA (SUCH AS SEX, WEIGHT AND AGE AT THE TIME OF EVENT) WAS REQUESTED ON 2024-12-24 BUT THE CUSTOMER NOT PROVIDED ANY DETAILS. ACCORDING TO THE SSU (SALES AND SERVICE UNIT) DATED ON 2025-01-19 THE MCP00702707# FLOW MEASURE BOARD FOR RFC (ARTICLE NUMBER: (B)(4) HAS BEEN REPLACED. A SIMILAR COMPLAINT WAS INVESTIGATED FOR THE REPORTED FAILURE IN THE GETINGE LIFE-CYCLE-ENGINEERING (LCE). THE REPORTED FAILURE WAS CAUSED MOST PROBABLY BY AN DEFECTIVE BUS TRANSCEIVER (IC3) ON THE FLOW MEASUREMENT BOARD. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "COM ERROR" COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-01-21 FOR THE PERIOD OF 2020-10-14 TO 2024-12-24. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW CONSOLE WAS PRODUCED IN 2020-10-14. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. FOR THE AFFECTED SERIAL NUMBER WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE CHINESE MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO ROTAFLOW, WHICH IS SOLD IN THE US. FOR D4 UNIQUE IDENTIFIER (UDI)# (B)4), PRIMARY DI NUMBER HAS BEEN USED FOR BASE UNIT, ROTAFLOW WITH CATALOG NUMBER 701046405. PROVIDED D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.
COMPLAINT ID: (B)(4).
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿COM ERROR¿ WAS DISPLAYED ON THE ROTFLOW CONSOLE DURING USE. THE DEVICE WAS SHUT DOWN AND THEN RESTARTED WHICH DID NOT SOLVE THE PROBLEM. THE CUSTOMER IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1347914 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706291#ROTAFLOW CHINESE ZH-PLUG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |