HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000275
- Event Type
- Death
- Date Received
- June 30, 2025
- Date of Event
- June 25, 2025
- Report Date
- January 8, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691773032
- PMA / PMN Number
- K943803
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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: THIS EVENT OCCURRED ON THE INDIA MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, HL 20¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K943803. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HL 20 WITH CATALOG NUMBER 701043262.
THE EVENT OCCURRED IN INDIA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE ERROR MESSAGE "HEAD" WAS DISPLAYED ON A HL20 PUMP WHICH CAUSED THE PUMP TO STOP. A GETINGE FIELD SERVICE TECHNICIAN WAS ONSITE FOR FURTHER INVESTIGATION AND FOUND THAT THE PUMP BELTS WERE BROKEN AND NEEDS TO BE REPLACED. PERFUSIONIST SHIFTED MAIN CIRCULATION CIRCUIT TO ANOTHER PUMP. NO HARM OF THE PATIENT HAS BEEN REPORTED DUE TO THE EXCHANGE OF THE PUMP. FURTHER INFORMATION PROVIDED BY THE SSU (SALES AND SERVICE UNIT) ON 2026-06-27 THAT AFTER THE SURGERY THE PATIENT WAS SHIFTED TO ICU AND THE NEXT DAY IN THE MORNING THE PATIENT PASSED AWAY. AT THAT TIME IN THE ICU WHEN THE PATIENT PASSED AWAY, THE PATIENT WAS NOT CONNECTED TO THE HL20. SINCE THE REPORTED ERROR MESSAGE: ¿HEAD¿ STOPPED THE PUMP AND THE PATIENT PASSED AWAY A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ONSITE FOR INVESTIGATION OF THE DEVICE. THE FST REPLACED THE BELT KIT. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. AS CONFIRMED BY THE GETINGE FST, THE BELTS HAVE NEVER BEEN REPLACED ON THAT DEVICE AND WERE OVERDUE FOR REPLACEMENT. ACCORDING TO THE HL20 SERVICE MANUAL, BELTS WHICH ARE FOUND TWISTED, HAVE WEAR, CRACKING, OR SERVICE LIFE OVER 12 MONTHS MUST BE REPLACED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-07-04 FOR THE PERIOD OF (B)(6) 2017 TO (B)(6) 2025. 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 DEVICE WAS MANUFACTURED ON 2017-10-11. 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 INVESTIGATION IS ONGOING. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN INDIA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE ERROR MESSAGE "HEAD" WAS DISPLAYED ON A HL20 PUMP WHICH CAUSED THE PUMP TO STOP. A GETINGE FIELD SERVICE TECHNICIAN WAS ONSITE FOR FURTHER INVESTIGATION AND FOUND THAT THE PUMP BELTS WERE BROKEN AND NEEDS TO BE REPLACED. THE PUMP WAS EXCHANGED WITH ANOTHER PUMP AND NO NEGATIVE CONSEQUENCES FOR THE PATIENT HAS BEEN REPORTED. NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) ON (B)(6) 2025. AFTER THE SURGERY, THE PATIENT WAS SHIFTED TO THE ICU (INTENSIVE CARE UNIT) AND PASSED AWAY THE NEXT MORNING (PATIENT WAS NOT CONNECTED TO THE HL20). THE REPORTED ERROR MESSAGE: ¿HEAD¿ STOPPED THE PUMP. A PATIENT¿S DEATH WAS REPORTED A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ONSITE FOR INVESTIGATION OF THE DEVICE ON (B)(6) 2025. THE FST REPLACED THE BELT KIT. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. AS CONFIRMED BY THE GETINGE FST, THE BELTS HAVE NEVER BEEN REPLACED ON THAT DEVICE AND WERE OVERDUE FOR REPLACEMENT SINCE (B)(6) 2018. ACCORDING TO THE HL20 SERVICE MANUAL, BELTS WHICH ARE FOUND TWISTED, HAVE WEAR, CRACKING, OR SERVICE LIFE OVER 12 MONTHS MUST BE REPLACED. THE AFFECTED BELTS (ARTICLE NUMBER (B)(4)) WERE INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) WITH THE FOLLOWING OUTCOME: DURING THE INVESTIGATION, THE ¿BROKEN BELTS¿ COULD BE CONFIRMED. BOTH BELTS WERE RUPTURED. ONE BELT SHOWED DAMAGE OVER THE WHOLE LENGTH WHILE THE OTHER APPEARED UNDAMAGED APART OF A 13CM SPLIT RUPTURE. THE BELTS WERE NOT REPLACED OR CHECKED IN THE LAST INSPECTION ABOUT TWO MONTHS PRIOR TO THE INCIDENCE. ACCORDING TO INFORMATION FROM THE SERVICE TECHNICIAN, THE BELTS WERE OVERDUE FOR REPLACEMENT. THE HL20 SYSTEM WAS MANUFACTURED IN (B)(6) 2017. THE MAINTENANCE PLAN REQUIRES REPLACEMENT OF THE RPM BELTS EVERY 12 MONTHS. THE MOST PROBABLE CAUSE OF FAILURE IS NEGLECT OF MAINTENANCE. THE BELTS WERE OPERATED ABOVE THEIR INTENDED SERVICE TIME. THIS CAUSED ONE OF THE BELTS TO TWIST AND SNAP, CAUSING THE SECOND BELT TO ALSO SNAP. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025- WITH FOLLOWING CONCLUSION: "THE INCIDENT INVOLVED AN HL20 SINGLE ROLLER PUMP FROM A VARIO TWIN HL20 SYSTEM, WHICH STOPPED DURING SURGERY ON (B)(6) 2025, DISPLAYING A ¿HEAD ERROR¿ ALARM. BASED ON INVESTIGATION FINDINGS, THE FAILURE INVOLVED THE HL20 RPM TRANSMISSION BELTS. THE INVESTIGATION CONFIRMED THAT BOTH BELTS WERE RUPTURED, WITH ONE BELT EXHIBITING DAMAGE ALONG ITS ENTIRE LENGTH AND THE SECOND BELT SHOWING A 13 CM SPLIT RUPTURE. THE AVAILABLE INFORMATION INDICATES THAT THE INCIDENT OCCURRED DUE TO A BROKEN BELT IN THE HL20 SINGLE ROLLER PUMP, WHICH HAD NOT BEEN REPLACED SINCE INSTALLATION OF THE HL20 IN 2017. FURTHER, BELT REPLACEMENT WAS OVERDUE AS PER THE SERVICE REQUIREMENTS OUTLINED IN THE HL20 SERVICE MANUAL. THE MANUAL SPECIFIES THAT BELTS SHOWING WEAR, TWISTING, CRACKING, OR MORE THAN 12 MONTHS OF USE MUST BE REPLACED DURING REGULAR MAINTENANCE BY AUTHORIZED SERVICE PERSONNEL. THE INVESTIGATION CONCLUDED THAT PROLONGED OPERATION BEYOND THE INTENDED SERVICE LIFE LIKELY CAUSED DEGRADATION OF ONE BELT, WHICH TWISTED AND RUPTURED, SUBSEQUENTLY CAUSING FAILURE OF THE SECOND BELT. THE ALARM CONDITION, ¿HEAD ERROR,¿ OCCURRED BECAUSE THE PUMP SPEED FELL BELOW 90% OF THE MOTOR SPEED, RESULTING IN AN AUTOMATIC PUMP STOP. THIS TECHNICAL EVIDENCE SUPPORTS THAT THE ROOT CAUSE OF THE MALFUNCTION WAS THE BROKEN BELT COMBINED WITH OVERDUE PREVENTIVE MAINTENANCE. THE DEVICE EXPERIENCED A MALFUNCTION, AS THE PUMP STOPPED DURING SURGERY AND DISPLAYED THE ERROR MESSAGE. THIS MALFUNCTION MAY BE ASSOCIATED WITH A TEMPORARY INTERRUPTION OF BLOOD FLOW; HOWEVER, THE PUMP WAS PROMPTLY REPLACED DURING THE PROCEDURE, AND THE SURGERY WAS COMPLETED WITHOUT REPORTED HARM AT THAT TIME. ACCORDING TO THE COMPLAINT NARRATIVE, THE PATIENT EXPIRED THE FOLLOWING DAY IN THE INTENSIVE CARE UNIT, WHEN THE HL20 DEVICE WAS NO LONGER IN USE. NO CLINICAL DETAILS, CAUSE OF DEATH, OR INFORMATION ON COMORBIDITIES WERE PROVIDED. WHILE A DIRECT CAUSAL LINK CANNOT BE CONFIRMED, THE INTERRUPTION OF BLOOD FLOW DUE TO THE PUMP STOP MAY HAVE CONTRIBUTED TO OR INFLUENCED THE PATIENT¿S CLINICAL STATUS. THAT SAID, AS HYPOTHERMIA IS COMMONLY DEPLOYED IN OPEN HEART PROCEDURES, IF HYPOTHERMIA HAD BEEN APPLIED TO THE PATIENT, THE LOWER TEMPERATURE WOULD HAVE AFFORDED A WIDENED MARGIN FOR RESUMPTION OF TARGET BLOOD FLOW DUE TO A REDUCTION IN METABOLIC DEMAND. THE PROPOSED HAZARDOUS SITUATION PRESENTED BY THE REPORTED EVENT WAS THE RISK OF INTERRUPTED PERFUSION. HOWEVER, THIS APPEARS TO HAVE BEEN MITIGATED BY REPLACEMENT THE AFFECTED PUMP DURING SURGERY. HOWEVER, NO INFORMATION IS AVAILABLE REGARDING HOW LONG IT TOOK TO REPLACE THE PUMP OR WHETHER A HAND CRANK WAS USED AS A MITIGATION, AND, THEREFORE, THE EXACT TIMELINE OF THE BLOOD FLOW INTERRUPTION IS UNKNOWN. IT SHOULD BE NOTED THAT THE CUSTOMER DID NOT RESPOND TO THE QUESTIONNAIRE THAT WAS SENT, SO UNFILLED GAPS IN DETAILS REMAIN. IN CONCLUSION, THE INCIDENT WAS CAUSED BY A BROKEN, OVERDUE-FOR-REPLACEMENT BELT IN THE HL20 PUMP, WITH THE INVESTIGATION CONFIRMING RUPTURE OF BOTH RPM TRANSMISSION BELTS DUE TO OPERATION BEYOND THEIR INTENDED SERVICE LIFE, CREATING A TEMPORARY RISK OF INTERRUPTED PERFUSION. WHILE THE PUMP WAS REPLACED AND NO IMMEDIATE HARM WAS REPORTED, THE POTENTIAL IMPACT ON THE PATIENT¿S CLINICAL STATUS CANNOT BE FULLY ASSESSED DUE TO LIMITED INFORMATION ON THE DURATION OF THE INTERRUPTION, ANY MITIGATION MEASURES TAKEN BY THE CUSTOMER, OR CONTRIBUTING PATIENT COMORBIDITIES." BASED ON THE INVESTIGATION THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2025 FOR THE PERIOD OF (B)(6) 2017 TO (B)(6) 2025. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE DEVICE WAS MANUFACTURED ON (B)(6) 2017. IN ORDER TO INVESTIGATE THE ¿OVERDUE BELT REPLACEMENT¿ FURTHER AN INTERNAL NONCONFORMITY WAS INITIATED. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED TILL (B)(6) 2025. THIS COMPLAINT WAS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. IN ORDER TO INVESTIGATE THE ¿HL 20 - OVERDUE BELT REPLACEMENT¿ FURTHER FSCA#(B)(4) WAS INITIATED ON (B)(6) 2025 RELATED TO THE REPORTED FAILURE AND PRODUCT AND TWO CAPAS WERE INITIATED TO THE RELATED FAILURE AND PRODUCT. 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, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTIONS FOR USE HEART-LUNG MACHINE HL 20 CHAPTER MAINTENANCE: MAINTENANCE INCLUDES ALL MEASURES WHICH ENSURE THE DEVICE IS FUNCTIONING PROPERLY AND IS FREE OF DAMAGE IN ORDER TO ENABLE SAFE USE FOR THE INTENDED PURPOSE. - INSPECTION AND MAINTENANCE BY AUTHORIZED SERVICE PERSONNEL EVERY 12 MONTHS (RPM BELT REPLACEMENT IS PART OF THE SERVICE ACTIVITIES) FURTHERMORE, IT IS DESCRIBED IN THE IFU IN CHAPTER GENERAL PRECAUTIONARY MEASURES DURING USE IF A PUMP STOP/FAILED DURING PATIENT TREATMENT: - ALWAYS KEEP A HAND CRANK TO HAND DURING THE TREATMENT. - THE HAND CRANK CAN BE USED TO DRIVE THE PUMP MANUALLY IF THE HL 20 SHOULD FAIL. - ALWAYS KEEP A REPLACEMENT UNIT ON STANDBY IN ORDER TO ENSURE CONTINUOUS OPERATION IN THE EVENT OF A COMPLETE SYSTEM FAILURE. THE CUSTOMER WILL ALSO BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL / HEART-LUNG MACHINE HL 20 CHAPTER 1.11 SERVICE ACTIVITIES: RPM BELT REPLACEMENT EVERY 12 MONTHS. 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 INDIA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE ERROR MESSAGE "HEAD" WAS DISPLAYED ON A HL20 PUMP WHICH CAUSED THE PUMP TO STOP. A GETINGE FIELD SERVICE TECHNICIAN WAS ONSITE FOR FURTHER INVESTIGATION AND FOUND THAT THE PUMP BELTS WERE BROKEN AND NEEDS TO BE REPLACED. PERFUSIONIST SHIFTED MAIN CIRCULATION CIRCUIT TO ANOTHER PUMP. NO HARM OF THE PATIENT HAS BEEN REPORTED DUE TO THE EXCHANGE OF THE PUMP. FURTHER INFORMATION PROVIDED BY THE SSU (SALES AND SERVICE UNIT) ON 2026-06-27 THAT AFTER THE SURGERY THE PATIENT WAS SHIFTED TO ICU AND THE NEXT DAY IN THE MORNING THE PATIENT PASSED AWAY. AT THAT TIME IN THE ICU WHEN THE PATIENT PASSED AWAY, THE PATIENT WAS NOT CONNECTED TO THE HL20. SINCE THE REPORTED ERROR MESSAGE: ¿HEAD¿ STOPPED THE PUMP AND THE PATIENT PASSED AWAY A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961848 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | MCP00706195#VARIO TWIN, HL 20, 4-PUMPS | 04037691773032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | Death |