HEART LUNG MACHINE
Report
- Report Number
- 8010762-2024-00176
- Event Type
- Death
- Date Received
- April 2, 2024
- Date of Event
- March 28, 2024
- Report Date
- July 31, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- 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. THE CUSTOMER ((B)(6) HOSPITAL) REPORTED THAT THE ERROR MESSAGE ¿OFFSET ERROR¿ OCCURRED DURING PATIENT TREATMENT ON THE ROTAFLOW CONSOLE, AND THE DEVICE STOPPED PUMPING. THE CUSTOMER USED THE EMERGENCY DRIVE. THERE WAS NO BACKUP MACHINE, SO THE FAMILY GAVE UP TREATMENT. THE PATIENT EXPIRED. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS ABLE TO REPRODUCE THE REPORTED FAILURE "OFFSET ERROR". THE (B)(6)#FLOW MEASURE BOARD FOR RFC (ARTICLE NUMBER (B)(4)) AND THE (B)(6)#POWER SUPPLY BOARD FOR RFC (ARTICLE NUMBER (B)(4)) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON (B)(6) 2024 AND DURING THE PERIOD OF (B)(6) 2022 TO (B)(6) 2024 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 (B)(6) 2022. THE ROOT CAUSE INVESTIGATION OF THE MANUFACTURER IS STILL ONGOING.
THE EVENT OCCURRED IN CHINA. THE CUSTOMER ((B)(6) HOSPITAL) REPORTED THAT THE ERROR MESSAGE ¿OFFSET ERROR¿ OCCURRED DURING PATIENT TREATMENT ON THE ROTAFLOW CONSOLE, AND THE DEVICE STOPPED PUMPING. THE CUSTOMER USED THE EMERGENCY DRIVE. THERE WAS NO BACKUP MACHINE, SO THE FAMILY GAVE UP TREATMENT. THE PATIENT EXPIRED. DUE TO THE REPORTED DEATH OF THE PATIENT A REPORT IS REQUIRED. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS ABLE TO REPRODUCE THE REPORTED FAILURE "OFFSET ERROR". THE MCP00702707#FLOW MEASURE BOARD FOR RFC (ARTICLE NUMBER 701011681) AND THE MCP00702711#POWER SUPPLY BOARD FOR RFC (ARTICLE NUMBER 701011675) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE AFFECTED MCP00702707#FLOW MEASURE BOARD FOR RFC (FMB) AND THE MCP00702711#POWER SUPPLY BOARD FOR RFC (PSB) WERE INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) WITH THE FOLLOWING OUTCOME: UPON VISUAL INSPECTION, DAMAGED CAPACITOR C44 AND INDUCTOR L1 WERE IDENTIFIED ON THE FMB. C44 AND L1 HAD SIGNS OF THERMAL DAMAGE AND THEIR SURROUNDINGS ON THE PCB WERE COLORED AS WELL. A BLOWN FUSE F2 WAS IDENTIFIED ON THE PSB, AND A SHORT CIRCUIT WAS CONFIRMED ON THE 12V POWER SUPPLY LINE OF THE FMB, WHICH COULD BE FIXED BY REMOVING THE AFFECTED COMPONENTS. AFTER BOARD MODIFICATION (REMOVING OR EXCHANGING AFFECTED COMPONENTS) THE RECEIVED PCBS WERE ASSEMBLED IN A ROTAFLOW SYSTEM AND TESTED. THE SYSTEM COULD BE OPERATED NORMALLY. THE REPORTED FAILURE WAS CAUSED MOST PROBABLY BY A SHORT CIRCUIT CAUSED BY A DEFECTIVE CAPACITOR C44 ON THE PSB WHICH CAUSED A LARGE AMOUNT OF CURRENT (>1A) TO BE DRAWN FROM THE 12 V VOLTAGE SUPPLY BLOWING UP THE FUSE AT THE PSB. A FURTHER ROOT CAUSE OF THE DEFECTIVE CAPACITOR IS PRESUMED TO BE A RANDOM DEFECT, THIS ASSUMPTION CANNOT BE VERIFIED IN THE SCOPE OF THIS REPORT. THE INVESTIGATION DETAILS WERE FORWARDED TO THE MANUFACTURER OF THE BOARDS. THE MANUFACTURER CANNOT INVESTIGATE THE BOARDS TECHNICALLY AS THEY STOPPED WORKING ON THESE COMPONENTS, PERSONNEL IS NO LONGER AVAILABLE. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS TEAM ON 2024-07-02 WITH THE FOLLOWING OUTCOME: THE COMPLAINT NARRATIVE DESCRIBES THE RESCUE ATTEMPT FOR A 33-YEAR-OLD PATIENT BY AN UNSPECIFIED FORM OF EXTRACORPOREAL SUPPORT. EIGHT (8) HOURS INTO SUPPORT, A DEFECT ON THE POWER SUPPLY BOARD LED TO A PUMP STOP. THE PUMP FLOW WAS TEMPORARILY RESTORED BY USE OF THE EMERGENCY DRIVE BY HOSPITAL PERSONNEL. AS NO BACKUP-CONSOLE WAS AVAILABLE THE FAMILY DECIDED TO TERMINATE SUPPORT. THE PATIENT EXPIRED. THE ERROR OCCURRENCE WAS CONFIRMED BY PHOTO-DOCUMENTATION AND THE SERVICE TECHNICIAN. BOTH THE FLOW- AND THE POWER-BOARD WERE REPLACED BEFORE THE CONSOLE WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION. AN INFORMATION REQUEST TO TECHNICAL SUPPORT WAS MADE TO FACILITATE A BETTER UNDERSTANDING OF THE EVENT. ACCORDING TO KNOWN OCCURRENCES IT IS POSSIBLE, THAT A POWER SURGE CAN TRIGGER THE FUSE F2 ON THE POWER BOARD, LEADING TO THE ALTERNATE-DIRECT (AD)-CONVERTER FAILING. THIS TRIGGERS BOTH AN ACOUSTIC ALARM AS WELL AS A PUMP STOP. IRREGULARITIES WITH THE HOSPITAL¿S POWER SUPPLY WERE NOT DETECTED AND THE EQUIPMENT WAS DEEMED TO BE IN WORKING ORDER. AS PER THE CONCLUSIONS IN THE LCE REPORT THE FAILURE AND SHORT CIRCUIT OF THE LINE FILTER OF THE 12V SUPPLY LINE MIGHT HAVE TWO POSSIBLE ROOT CAUSES: A RANDOM FAILURE OF THE AFFECTED ELECTRONIC PARTS OR, A VOLTAGE-SURGE. THE SUDDEN CESSATION OF SUPPORT LEAD TO A DETERIORATION OF THE PATIENT¿S CONDITION. THE HOSPITAL HAS ONE ROTAFLOW CONSOLE, WHICH WAS ALREADY IN USE IN ANOTHER CASE AT THE TIME OF THE EVENT. THE EMERGENCY DRIVE, TO BE USED IN CASE OF ANY PUMP DRIVE FAILURE, IS USED TO BRIDGE SUPPORT, UNTIL A REPLACEMENT CONSOLE CAN BE MADE READY, AS SUCH IS NOT AN INSTRUMENT INTENDED FOR LONG TERM SUPPORT. AS NO REPLACEMENT WAS AVAILABLE THE FAMILY DECIDED TO FOREGO FURTHER SUPPORT RESULTING IN THE EXPIRATION OF THE PATIENT. THE CONSUMPTION AND INTOXICATION WITH ALCOHOL CAN LEAD TO A VARIETY OF SYMPTOMS AND AFFECTED ORGAN SYSTEMS, DEPENDENT UPON THE CONSUMED DOSAGE. IN CASES OF SEVERE ALCOHOL INTOXICATION, UNCONSCIOUSNESS, ASPIRATION AND RESPIRATORY DEPRESSION OR ARREST MAY OCCUR. THE DEPRESSION OF THE BREATHING REFLEX IS THE ONE OF THE MOST HAZARDOUS SITUATIONS AND CAN LEAD TO CARDIOPULMONARY ARREST DUE TO HYPOXIA. THE PATIENT WAS BROUGHT TO THE HOSPITAL IN ¿AGGRAVATED APNEA¿, SUPPOSEDLY DUE TO HEAVY DRINKING, AND IN VIEW OF THE CUSTOMER, ¿RELATIVELY LATE¿. THE STATEMENT OF THE PATIENT BEING PAST ¿THE BEST RESCUE TIME¿ MAY INDICATE THAT THE TREATMENT WAS UNDERTAKEN AS A RESCUE EFFORT FOR A RELATIVELY YOUNG PATIENT, WHO WAS ALSO A HOSPITAL EMPLOYEE. THE PRECARIOUS PATIENT CONDITION MAY HAVE HAD AN EFFECT ONTO THE PATIENT¿S PROGNOSIS. THE DEFINITE ROOT CAUSE OF THE DEFECTIVE POWER AND FLOW-BOARD REMAINS UNCLEAR. THE DEFECTIVE PARTS, AS EXAMINED BY GETINGE, POINT TO THE MOST LIKELY ROOT CAUSE BEING ¿A RANDOM FAILURE¿, AS FLUCTUATIONS OF THE POWER NET WERE EXCLUDED BY THE CUSTOMER IN QUESTION 5 OF THE QUESTIONNAIRE REGARDING THE ICU POWER SUPPLY WITH: "NO IRREGULARITIES¿. THE LOSS OF FUNCTION IN THE ROTAFLOW CONSOLE CAUSED A PUMP STOP, REQUIRING THE USE OF THE EMERGENCY DRIVE AND ULTIMATELY LEADING TO THE EARLY EXPIRATION OF THE PATIENT, AS, IN ABSENCE OF A REPLACEMENT CONSOLE, THE PATIENT COULD NOT BE SUPPORTED FURTHER. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "OFFSET ERROR" COULD BE CONFIRMED, BUT NO EXACT ROOT CAUSE COULD BE DETERMINED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-04-24 AND DURING THE PERIOD OF 2022-03-15 TO 2024-03-28 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 2022-03-15. 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. SINCE NO SYSTEMIC ISSUE COULD BE DETERMINED CONSEQUENTLY, THERE WAS NEITHER A STARTING POINT FOR CORRECTIONS, CORRECTIVE ACTIONS OR FSCA NOR WERE THESE ACTIONS NECESSARY. 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. THE CUSTOMER ((B)(6) HOSPITAL) REPORTED THAT THE ERROR MESSAGE ¿OFFSET ERROR¿ OCCURRED DURING PATIENT TREATMENT ON THE ROTAFLOW CONSOLE, AND THE DEVICE STOPPED PUMPING. THE HOSPITAL RESCUED THE PATIENT IN TIME. THE PATIENT DIED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767613 | 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 | 33 YR | Male | Death |