HEART LUNG MACHINE
Report
- Report Number
- 8010762-2024-0000465
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Report Date
- November 25, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE ¿B TEMP ERROR¿ MESSAGE OCCURRED ON THE ROTAFLOW CONSOLE DURING USE. THE POWER SUPPLY BOARD WAS DETECTED AS DEFECTIVE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿B TEMP¿ COULD LEAD TO THE PUMP STOP, THEREFORE A REPORT IS REQUIRED. A GETINGE SERVICE TECHNICIAN WAS ON SITE TO REPAIR THE AFFECTED ROTAFLOW CONSOLE (SERIAL#94175867). THE TECHNICIAN REPLACED THE RFC (ROTAFLOW CONSOLE) POWER SUPPLY BOARD (MATERIAL# 70101.1675). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. AN INVESTIGATION OF A ROTAFLOW SYSTEM THAT EXHIBITED A SIMILAR ISSUE "B TEMP ERROR (POWER SUPPLY BOARD DEFECT)" WAS PERFORMED IN GETINGE LIFE CYCLE ENGINEERING. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS THE FOLLOWING: A DEFECT CAPACITOR C21 ON THE POWER SUPPLY BOARD AS WELL AS AGE RELATED FACTORS. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-09-24 AND DURING THE PERIOD OF 2006-12-20 TO 2024-09-20 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 IN QUESTION WAS PRODUCED IN 2006-12-20. 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW) HAS BEEN MANUFACTURED ON 2006. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.
(B)(4).
THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE ¿B TEMP ERROR¿ MESSAGE OCCURRED ON THE ROTAFLOW CONSOLE DURING PATIENT TREATMENT. THE POWER SUPPLY BOARD WAS DETECTED AS DEFECTIVE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THIS BEHAVIOR CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS NEEDED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1708965 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00703169#RFC 20-970 ROTAFLOW CONSOLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |