HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000073
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- February 17, 2025
- Report Date
- September 1, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 DRIVE) HAS BEEN MANUFACTURED ON 2012. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT A TYPOGRAPHICAL ERROR IDENTIFIED IN BOTH INITIAL AND FINAL REPORTS SUBMITTED FOR THE COMPLAINT (B)(4). MFG REPORT NUMBER 8010762-2025-0000073. THE REPORTS PREVIOUSLY STATES THAT THE EVENT OCCURRED IN CHINA. THIS WAS AN ERROR. THE EVENT, IN FACT, OCCURRED IN JAPAN. PLEASE NOTE: THE CUSTOMER´S ADDRESS, INCLUDING THE CORRECT JAPANESE LOCATION, WAS CORRECTLY ENTERED IN THE RELEVANT ADDRESS FIELDS IN THE PRIOR REPORT SUBMISSION. THIS CORRECTION DOES NOT IMPACT THE INVESTIGATION FINDINGS, ROOT CAUSE ANALYSIS, OR THE CONCLUSIONS PRESENTED IN THE PREVIOUS REPORT. THEREFORE, FOR REFERENCE, PLEASE SEE THE INVESTIGATION FINDINGS, PREVIOUSLY SENT, BELLOW: THE EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE DURING ROUTINE INSPECTION. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) AND THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE CUSTOMER CONFIRMED NOT TO ORDER ANY REPAIR OF THE ROTAFLOW DRIVE AT THIS TIME. BASED ON THESE INVESTIGATION RESULTS THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE "HEAD ERROR" IS MOST PROBABLY CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-02-17 FOR THE PERIOD OF 2025-02-17 TO 2012-10-08. IT SHOWS NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE COMPLAINT INFORMATION WAS TRANSFERRED TO THE INTERNAL NONCONFORMITY PROCESS. THE ROTAFLOW DRIVE WITH S/N (B)(6) WAS PRODUCED IN 2012-10-08. 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. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE THE ROTAFLOW CONSOLE MAY BE DAMAGED. 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 EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE DURING ROUTINE INSPECTION. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW DRIVE (RFD) WITH S/N: (B)(6) AND THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE CUSTOMER CONFIRMED NOT TO ORDER ANY REPAIR OF THE ROTAFLOW DRIVE AT THIS TIME. BASED ON THESE INVESTIGATION RESULTS THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE "HEAD ERROR" IS MOST PROBABLY CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT, THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-02-17 FOR THE PERIOD OF 2025-02-17 TO 2012-10-08. IT SHOWS NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE COMPLAINT INFORMATION WAS TRANSFERRED TO THE INTERNAL NONCONFORMITY PROCESS. THE ROTAFLOW DRIVE WITH S/N: (B)(6) WAS PRODUCED IN 2012-10-08. 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. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE, THE ROTAFLOW CONSOLE MAY BE DAMAGED. 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 EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW DRIVE DURING ROUTINE INSPECTION. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: 1230526
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1693638 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW DRIVE UNIT, BLUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |