HEART LUNG MACHINE
Report
- Report Number
- 3008355164-2023-00018
- Event Type
- Death
- Date Received
- May 11, 2023
- Date of Event
- May 9, 2023
- Report Date
- November 8, 2023
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. THE ROTAFLOW CONSOLE AND DRIVE WILL BE SENT TO GERMANY FOR FURTHER INVESTIGATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN AUSTRALIA. THE FOLLOWING WAS REPORTED. PATIENT HAD CARDIAC SURGERY (CAGS) ¿ IT WAS FAILED TO WEAN THE PATIENT FROM BYPASS MACHINE AT THE END OF THE CASE ¿ PATIENT WAS CANNULATED AND TRANSFERRED TO ROTAFLOW ECMO MACHINE - BY INSTIGATION OF FLOW THE TECHNICAL ERROR MESSAGE ¿DEL ERROR¿ APPEARED ON THE ROTAFLOW CONSOLE - CUSTOMER STATED THAT THE FLOW SUPPORT SEEMED TO CONTINUE DESPITE THIS ISSUE. ON TROUBLESHOOTING THE COMMUNICATED MESSAGE THE CUSTOMER COULD NOT CLEAR THE MESSAGE AND THE FLOW SEEMED TO STOP. AT THIS STAGE THE CUSTOMERS HAD TO COMMENCE INTERNAL CARDIAC MASSAGE FOR 20MINUTES WHILST THEY DECIDED TO PUT THE PATIENT BACK ON THE BYPASS MACHINE (NON ECMO) DUE TO NOT HAVING A BACK-UP ROTAFLOW MACHINE OR USING THE EMERGENCY HAND-CRANK. UNFORTUNATELY THE PATIENT DETERIORATED SUBSTANTIALLY DESPITE BEING PUT BACK ON THE BYPASS MACHINE AND THE DECISION WAS MADE TO CEASE TREATMENT. THE PATIENT EXPIRED. FURTHER, THE COMPLAINT REPORT EXPRESSED THAT THE CUSTOMER WAS UNWILLING TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT. THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE "DEL ERROR" COULD NOT BE REPRODUCED. DURING FURTHER INVESTIGATION ERROR MESSAGE "HEAD ERROR" OCCURRED. THE CUSTOMER WAS PROVIDED WITH A LOANER UNIT. THE ROTAFLOW CONSOLE (RFC) AND THE ROTAFLOW DRIVE (RFD) WAS SENT BACK TO MANUFACTURER FOR REPAIR. DURING THE INVESTIGATION BY THE GETINGE SERVICE DEPARTMENT ON 2023-09-26 THE REPORTED "DEL ERROR" COULD NOT BE REPRODUCED HOWEVER, THE "HEAD ERROR" COULD BE CONFIRMED. THE RFC CONTROL BOARD KIT (ARTICLE NUMBER 701034051) AND THE RFD HAS BEEN CONFIRMED AS DEFECTIVE. THE RFC CONTROL BOARD KIT (ARTICLE NUMBER 701034051) HAS BEEN REPLACED ON THE RFC. AS A PRECAUTION THE RFC FLOW MEASURE BOARD (ARTICLE NUMBER 701011681) HAS BEEN REPLACED AS WELL. THE ROTAFLOW DRIVE WITH S/N (B)(6) WILL BE SEND TO THE SUPPLIER (B)(4) FOR REPAIR. A SIMILAR COMPLAINT ((B)(4)) WAS INVESTIGATED FOR THE REPORTED FAILURE "DEL ERROR" BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE). THE REPORTED FAILURE WAS CAUSED MOST PROBABLY BY AN MECHANICAL INFLUENCE DURING MAINTENANCE. A SOLDER JOINT OF THE POTENTIOMETER POT3 IS BROKEN WHICH DISTURBS THE AMPLIFICATION OF THE ULTRASONIC SIGNALS AND DISRUPTS THE FLOW MEASUREMENT. ACCORDING TO THE STATEMENT OF THE LIFE CYCLE ENGINEERING (LCE) ¿THE ¿DEL¿ ERROR COULD APPEAR DURING STARTUP OF THE DEVICE DURING SELF-TEST OR MAINTENANCE. THIS IS ONE OF THE SELF-TEST ROUTINES IN WHICH THE TIME MEASUREMENT IS CHECKED ON THE FLOW MEASURING BOARD, SINCE VERY SENSITIVE SIGNALS ARE MEASURED." 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. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS TEAM ON 2023-08-22 WITH THE FOLLOWING OUTCOME: THE COMPLAINT REPORT, QUESTIONNAIRE, AND SUBSEQUENT FOLLOW-UP CORRESPONDENCE WERE CAREFULLY REVIEWED. THE ERROR MESSAGE WAS REVIEWED BY INTERNAL STAKEHOLDERS, INCLUDING LCE INVESTIGATION TEAM AND THE DESIGNATED COMPLAINTS UNIT. ACCORDING TO THE LCE INVESTIGATION, THE ERROR MESSAGE ¿ERR DEL¿ IS A RESULT OF A BROKEN SOLDER JOINT ON THE FLOW MEASUREMENT BOARD (FMB). THE TECHNICAL DESCRIPTION FOLLOWS THAT IDENTIFIED THE SEQUENCE OF EVENTS AND MOST PROBABLE ROOT CAUSE LEADING TO THE FAILURE MODE AND EFFECTS DESCRIBED IN THE COMPLAINT. ¿A SOLDER JOINT OF POTENTIOMETER POT3 IS BROKEN. THIS DISTURBS THE AMPLIFICATION OF THE ULTRASONIC SIGNALS AND DISRUPTS THE FLOW MEASUREMENT. THIS EXPLAINS THE REPORTED FAILURE. MOST PROBABLE ROOT CAUSE IS A MECHANICAL INFLUENCE DURING MAINTENANCE. POT3 REGULATES THE GAIN OF THE SENSE AMPLIFIER BEFORE THE ADC. SINCE THE CONNECTION ON THE POTENTIOMETER WIPER HAS BROKEN OFF, CONTROL IS NO LONGER POSSIBLE. THIS MEANS THAT THE ULTRASONIC MEASURING SYSTEM NO LONGER WORKS. A POSSIBLE CAUSE OUTSIDE THE FMB IS NOT KNOWN¿. THE DESCRIPTION OF THE ERROR MESSAGE WAS REVIEWED IN THE PRODUCT DOCUMENTATION (IFU) AVAILABLE TO THE CUSTOMER. THE ¿ERR DEL¿ IS DESCRIBED IN THE IFU SUBSECTION 8.1.2 IS A ¿DELAY LINE OF FLOW SENSOR¿ THE TECHNICAL ERROR PRESENTED AT START UP IS ACCOMPANIED BY A VISUAL MESSAGE, AN ACOUSTIC ALARM, AND IS ASSOCIATED WITH A PUMP STOP. THE SYSTEM IS LOCKED-OUT AND PUMP FLOW CANNOT BE INITIATED. THE SYSTEM BEHAVIOR AS DESCRIBED IS CONSISTENT WITH THE OBSERVATIONS REPORTED BY THE CLINIC. A REVIEW OF THE CLINICAL SEQUENCE OF EVENTS LEADING TO THE UNFORTUNATE PATIENT OUTCOME MAY BE ASSOCIATED WITH A DELAY IN SUPPORT SECONDARY TO A DEVICE MALFUNCTION. THE DELAY IN TREATMENT RESULTED DURING A TIME SENSITIVE CLINICAL SCENARIO (CARDIAC ARREST AND RESUSCITATION). THE OUTCOME OF THE PATIENT MAY HAVE BEEN ASSOCIATED WITH MULTIPLE COMORBIDITIES PRIOR TO THE EVENT; HOWEVER, THESE WERE NOT DESCRIBED OR INCLUDED IN THE EITHER THE COMPLAINT NARRATIVE OR CORRESPONDENCE. FURTHER, THE COMPLAINT REPORT EXPRESSED THAT THE CUSTOMER WAS UNWILLING TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT. THEREFORE, AN ASSESSMENT OF POSSIBLY CONTRIBUTING PATIENT FACTORS/INFLUENCES REGARDING PATIENT COURSE AND OUTCOME PROVES CHALLENGING. THE OUTCOME MAY HAVE BEEN EXACERBATED BY A USE ERROR PRIOR TO THE EVENT AND POSSIBLY DURING THE EVENT. THE LACK OF A BACKUP ROTAFLOW SYSTEM BEARS MENTIONING AND IS CONSIDERED AN IMPORTANT MITIGATION TO ADDRESS FAILURE MODES OF ALL TYPES FOR LIFE SUPPORT EQUIPMENT. ADDITIONALLY, THE CUSTOMER EXPRESSED THAT AN EMERGENCY DRIVE WAS NOT AVAILABLE. ACCORDING TO THE COMPLAINT NARRATIVE, THE CIRCUIT WAS PRE-PRIMED. NO INDICATION IS MADE OF ANY ERROR MESSAGES DURING PRE-PRIMING; THEREFORE, IT IS ASSUMED THAT THE MESSAGE OCCURRED AFTER PRE-PRIMING BUT BEFORE USE. THE ROTAFLOW INSTRUCTIONS FOR USE (IFU) MAKES THE FOLLOWING STATEMENTS REGARDING THE AVAILABILITY OF THE EMERGENCY DRIVE IN CHAPTER 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE "ALWAYS KEEP THE ROTAFLOW EMERGENCY DRIVE AT THE READY FOR STOP-GAP MANUAL OPERATION IN THE EVENT OF PUMP DRIVE FAILURE." A FAILURE OF THE ROTAFLOW SELF-TEST IS ADDRESSED IN THE ROTAFLOW INSTRUCTIONS FOR USE (IFU) IN CHAPTER 5.4.1 SWITCHING ON THE CONSOLE, SELF-TEST "IF THE FOLLOWING SELF-TEST IS NOT PASSED, DO NOT OPERATE THE DEVICE AND HAVE IT TESTED BY AUTHORIZED SERVICE PERSONNEL." IF THE ¿ERR DEL¿ MESSAGE OCCURRED DURING POWER-UP OF THE ROTAFLOW CONSOLE, AS REPORTED IN THE COMPLAINT NARRATIVE, INVESTIGATION OF THE DEVICE BY AN AUTHORIZED GETINGE REPRESENTATIVE AND EXCHANGE WITH ANOTHER FUNCTIONAL SUPPORT DEVICE WOULD HAVE BEEN THE MITIGATING RECOMMENDATION. THERE IS A PAUCITY OF CLINICAL INFORMATION ASSOCIATED WITH MANAGEMENT OF THE PATIENT DURING THIS EVENT THAT LIMITS FURTHER ASSESSMENT OF USE RELATED FACTORS THAT MAY HAVE (OR MAY NOT HAVE) CONTRIBUTED TO THE OUTCOME OF THE PATIENT. A 20-MINUTE INTERVAL OF OPEN-HEART MASSAGE WAS REPORTED. HAND-CRANKING AND CHANGEOUT OF THE ROTAFLOW CONSOLE ARE THE RECOMMENDED INTERVENTIONS, WHICH MAY HAVE ALTERED THE CLINICAL COURSE. THE MAIN MITIGATIONS FOR A CONSOLE FAILURE RELIES ON HANDCRANKING AND/OR A CONSOLE EXCHANGE. THE INABILITY TO PROVIDE SUFFICIENT BLOOD FLOW (I.E., VIA HAND-CRANK OR A FUNCTIONAL CENTRIFUGAL PUMP SYSTEM) DURING THE 20-MINUTE RESUSCITATION MAY HAVE CONTRIBUTED TO THE PATIENT DISPOSITION AND OUTCOME. WHILE IT IS POSSIBLE THAT THE INABILITY TO INITIALLY GENERATE FLOW (SECONDARY TO AN INTERNAL CIRCUIT BOARD MALFUNCTION OF THE ROTAFLOW CONSOLE) MAY HAVE EXACERBATED THE INITIAL PRESENTATION OF CARDIOGENIC SHOCK (I.E., BARRING MORE DETAILS ABOUT PATIENT PRESENTATION), RESTORATION OF BLOOD FLOW MAY HAVE BEEN ABLE TO HAVE BEEN ACHIEVED VIA EITHER EXCHANGE OF THE ROTAFLOW CONSOLE OR DEPLOYMENT OF THE EMERGENCY DRIVE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "DEL ERROR" COULD NOT BE CONFIRMED. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2023-05-11 AND DURING THE PERIOD OF 2017-10-10 TO 2023-05-10 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 AFFECTED ROTAFLOW CONSOLE IN WITH S/N (B)(6) WAS PRODUCED IN 2017-10-10. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2023-09-01 AND DURING THE PERIOD OF 2017-10-10 TO 2023-09-01 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 AFFECTED ROTAFLOW DRIVE WITH S/N (B)(6) WAS PRODUCED IN 2017-10-10. 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 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE ALWAYS KEEP THE ROTAFLOW EMERGENCY DRIVE AT THE READY FOR STOP-GAP MANUAL OPERATION IN THE EVENT OF PUMP DRIVE FAILURE. CHAPTER 4.1.4 POSITIONING THE ROTAFLOW EMERGENCY DRIVE FIT THE ROTAFLOW EMERGENCY DRIVE NEAR THE ROTAFLOW DRIVE. ENSURE YOU WILL BE ABLE TO SWAP THE ROTAFLOW CENTRIFUGAL PUMP FROM THE ROTAFLOW DRIVE TO THE ROTAFLOW EMERGENCY DRIVE QUICKLY IN AN EMERGENCY. CHAPTER 5.6.1 CHECK BEFORE EVERY USE ROTAFLOW EMERGENCY DRIVE IS AVAILABLE AND SECURELY FIXED. CHAPTER 5.4.1 SWITCHING ON THE CONSOLE, SELF-TEST IF THE FOLLOWING SELF-TEST IS NOT PASSED, DO NOT OPERATE THE DEVICE AND HAVE IT TESTED BY AUTHORIZED SERVICE PERSONNEL. FOR "HEAD ERROR" FOLLOW 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 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.
NEW INFORMATION ABOUT A SECOND FAILURE HAS BEEN PROVIDED BY THE GETINGE FIELD SERVICE TECHNICIAN DATED ON 2023-08-23. THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED DURING THE INVESTIGATION OF THE ROTAFLOW CONSOLE AND DRIVE. THE ROTAFLOW CONSOLE AND DRIVE WILL BE SENT TO GERMANY FOR FURTHER INVESTIGATION. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
THE EVENT OCCURRED IN AUSTRALIA. IT WAS THE FOLLOWING REPORTED. PATIENT HAD CARDIAC SURGERY (CAGS) ¿ IT WAS FAILED TO WEAN THE PATIENT FROM BYPASS MACHINE AT THE END OF THE CASE ¿ PATIENT WAS CANNULATED AND TRANSFERRED TO ROTAFLOW ECMO MACHINE - BY INSTIGATION OF FLOW THE TECHNICAL ERROR MESSAGE ¿DEL ERROR¿ APPEARED ON THE ROTAFLOW CONSOLE - CUSTOMER STATED THAT THE FLOW SUPPORT SEEMED TO CONTINUE DESPITE THIS ISSUE. ON TROUBLESHOOTING THE COMMUNICATED MESSAGE THE CUSTOMER COULD NOT CLEAR THE MESSAGE AND THE FLOW SEEMED TO STOP. AT THIS STAGE THE CUSTOMERS HAD TO COMMENCE INTERNAL CARDIAC MASSAGE FOR 20 MINUTES WHILST THEY DECIDED TO PUT THE PATIENT BACK ON THE BYPASS MACHINE (NON ECMO) DUE TO NOT HAVING A BACK-UP ROTAFLOW MACHINE OR USING THE EMERGENCY HAND-CRANK. UNFORTUNATELY THE PATIENT DETERIORATED SUBSTANTIALLY DESPITE BEING PUT BACK ON THE BYPASS MACHINE AND THE DECISION WAS MADE TO CEASE TREATMENT. THE PATIENT EXPIRED. FURTHERMORE IT WAS STATED BY THE SSU (SALES AND SERVICE UNIT), ¿THE CUSTOMER PROVIDED LOAN UNIT AND WE HAVE REQUESTED TO HAVE MACHINE IN QUESTION SENT TO US FOR ENGINEERING REVIEW. CUSTOMER ADVISED THAT A BACK-UP MACHINE SHOULD HAVE BEEN ON SITE AND THAT THE EMERGENCY HAND-CRANK COULD HAVE BEEN USED WHILST A BACK-UP MACHINE WAS SOURCED. PLEASE DON'T ASK GETINGE SSU FOR THE PATIENT DETAILS FOR THIS COMPLAINT AS THE CUSTOMER IS NOT WILLING TO SHARE THEM DUE TO CONFIDENTIALITY REASONS.¿ COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774035 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW ENGLISH/UK UK-PLUG ICU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | HOSPITAL UNWILLING TO SHARE DETAILS. |