HEART LUNG MACHINE
Report
- Report Number
- 8010762-2022-00421
- Event Type
- Malfunction
- Date Received
- October 25, 2022
- Date of Event
- October 18, 2022
- Report Date
- December 2, 2022
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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.
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE (RFC) DURING PATIENT USE. THE EMERGENCY DRIVE WAS USED TO CONTINUE RUNNING THE DEVICE. THE RFC WAS RESTARTED AFTER A PERIOD OF TIME AND RETURNS TO NORMAL. THE DEVICE WAS USED FOR 2 DAYS AND THEN WITHDRAWS THE MACHINE. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6). THE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED "HEAD ERROR" AFTER LONG TESTING THE DEVICE. THE RFC CONTROL BOARD PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) KIT (ARTICLE NUMBER (B)(4) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE FOLLOWING MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED FOR THE HEAD ERROR: THE HEAD ERROR IS 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. IF THE RPM / LPM IS SET TO ZERO AND THE DRIVE AS WELL AS THE INSERTED CENTRIFUGAL PUMP IS SHAKEN THIS CAUSES MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP AND THUS LEADS TO THE HEAD ERROR. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED IN (B)(6) 2022. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON (B)(6) 2022. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, 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 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 CONSOLE (RFC) DURING PATIENT USE. THE EMERGENCY DRIVE WAS USED TO CONTINUE RUNNING THE DEVICE. THE RFC WAS RESTARTED AFTER A PERIOD OF TIME AND RETURNS TO NORMAL. THE DEVICE WAS USED FOR 2 DAYS AND THEN WITHDRAWS THE MACHINE. THE INVESTIGATION OF THE RFC IS ONGOING. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391102 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706291#ROTAFLOW PUMP MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |