HEART LUNG MACHINE
Report
- Report Number
- 3008355164-2022-00005
- Event Type
- Death
- Date Received
- March 1, 2022
- Date of Event
- February 10, 2022
- Report Date
- March 31, 2022
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY
- 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 THE US. CUSTOMER STATED THAT THE ROTAFLOW CONSOLE WAS RUNNING ON BATTERY FOR A SHORT PERIOD OF TIME. BATTERY VOLTAGE STARTED AT 28 VOLTS AND DROPPED TO 17 VOLTS AND SHUT DOWN WHILE ON A PATIENT WITHIN 5 MINUTES OF OPERATION. THE CUSTOMER USED THE HAND CRANK DURING USE. THE PATIENT WAS MAINTAINED ON ECMO FOR ANOTHER 10 DAYS AND THEN EXPIRED. THE ROTAFLOW CONSOLE WITH S/N (B)(4) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN DATED ON 2022-02-10 AND HE WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. AS A PRECAUTION THE BATTERYPACK NI-CD 24V 132WH (RFC - ROTAFLOW CONSOLE) (ARTICLE 701017188) HAS BEEN REPLACED. THE BATTERY WAS DUE FOR REPLACEMENT IN MARCH 2022. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER SPECIFICATIONS. THE UNIT WAS RETURNED TO CUSTOMER AND IS BACK IN USE. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS ON 2022-03-28 WITH THE FOLLOWING OUTCOME: THE ROTAFLOW CONSOLE WAS THOROUGHLY INVESTIGATED BY GETINGE SERVICE, BUT DID NOT DISPLAY ANY DEFICIENCIES OR SHORTCOMINGS IN PERFORMANCE. THEREFORE, THE DEVICE MET THE ¿PUNCH-OUT¿ CRITERIA FOR RELEASE BACK TO CLINICAL SERVICE. MOREOVER, THE ORIGINAL BATTERY WAS INSPECTED BEFORE THE EXCHANGE WITH A NEW BATTERY AND DID NOT APPEAR DISPLAY ANY DEFICIENCIES. THE THREE INDICATOR LIGHTS (AC POWER, BATTERY CHARGING, AND BATTERY OPERATION) ALL APPEARED TO BE FUNCTIONAL ACCORDING TO THE SERVICE REPORT. GIVEN THE AVAILABLE EVIDENCE, IT IS CHALLENGING TO ASSIGN A ROOT CAUSE OF THE ROTAFLOW POWER DOWN TO INSUFFICIENT PERFORMANCE OF THE ROTAFLOW CONSOLE ITSELF, TO THE INTERNAL COMPONENTS OF THE ROTAFLOW, OR TO THE POWER AND/OR BATTERY INDICATORS. HOWEVER, A LIKELY ROOT CAUSE MAY BE THAT THE ROTAFLOW CONSOLE WAS REMOVED FROM AC POWER BEFORE IT WAS FULLY CHARGED. THE EMAIL CORRESPONDENCE INDICATED THE BATTERY CHARGING LAMP WAS LIT (I.E. ACTIVELY ON) BEFORE THE OCCURRENCE OF THE POWER-DOWN EVENT. THIS SIGNALS THAT THE BATTERY WAS NOT FULLY CHARGED AT THE TIME THE ROTAFLOW SYSTEM WAS REMOVED FROM WALL VOLTAGE. MOREOVER, THE EXTERNAL POWER SUPPLY LAMP WAS STATED TO HAVE BEEN LIT (I.E. ACTIVELY ON) WHICH INDICATED THE ROTAFLOW CONSOLE WAS PROPERLY CONNECTED TO WALL POWER WITH THE BREAKER IN THE CORRECT (ON) POSITION. WITH BOTH THE EXTERNAL SUPPLY LAMP AND THE BATTERY CHARGING LAMP BOTH LIT (I.E. ACTIVELY ON), IT IS ASSUMED THAT THE ROTAFLOW CONSOLE WAS PROPERLY CONNECTED TO WALL POWER AND ACTIVELY CHARGING, BUT NOT FULLY CHARGED AS THE BATTERY CHARGING INDICATOR WOULD HAVE BEEN OFF (I.E. UNLIT). AS EXPLAINED IN THE EMAIL CORRESPONDENCE, THE LATEST BATTERY CHECK WAS PERFORMED IN SEPTEMBER 2021. IT IS ASSUMED THAT IF THE BATTERY HAD DISPLAYED INSUFFICIENT PERFORMANCE AT THE TIME OF THE SEPT 2021 BATTERY CHECK, A BATTERY REPLACEMENT WOULD BEEN PERFORMED PER SERVICE PROTOCOL. THE COMPLAINT NARRATIVE COMMENTS THAT THE ROTAFLOW CONSOLE DISPLAYED A VOLTAGE OF 17 BEFORE SHUTTING OFF. HOWEVER, THE ROTAFLOW INSTRUCTIONS FOR USE (IFU) SHOWS THAT THE ROTAFLOW CONSOLE IS DESIGNED TO SHUT DOWN AT 19 VOLTS OF BATTERY CAPACITY. ADDITIONALLY, AN UNMUTABLE ALARM WHICH SIGNALS LOW VOLTAGE AND A LOW BAT VISUAL SHOULD BE SHOWN IN THE SPEED AND POWER DISPLAYS. NEITHER THE EXPECTED AUDIBLE NOR THE VISUAL ALARMS WERE MENTIONED IN THE CONTEXT OF THE COMPLAINT. FINALLY, THE COMPLAINT NARRATIVE INDICATES THAT THE PATIENT EXPIRED TEN (10) DAYS POST-EVENT. THIS SUGGESTS THAT THE EXPIRATION OF THE PATIENT IS NOT LIKELY RELATED TO THE POWER-DOWN EVENT EXPRESSED/WITNESSED BY THE CUSTOMER. FURTHERMORE, THE COMPLAINT STATED THAT THE PATIENT WAS SUPPORTED BY THE ROTAFLOW EMERGENCY DRIVE WHILE THE ROTAFLOW CONSOLE WAS POWERED OFF. BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. HOWEVER, THE FAILURE MODE "SHUT DOWN DURING TRANSPORT" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS#2023689) * PUMP STOP INTERVENTION AFTER TECHNICAL ERROR (E.G. PUMP RUNAWAY, ERROR HEAD). * WRONG INTERVENTION LIMITS. * UNINTENDED RPM CHANGE BY USER. * UNINTENDED SWITCH OFF BY USER. * USER FORGOT RECHARGE. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2022-02-22 DURING THE PERIOD OF 2015-08-11 TO 2022-02-22 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 2015-08-11. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, THE SALES AND SERVICE UNIT (SSU) WILL BE INFORMED TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / V15. CHAPTER 3.3.4: CHECK BATTERY CAPACITY EVERY 6 MONTHS, AT THE LATEST. THE BATTERY MUST BE REPLACED BY THE AUTHORIZED TECHNICAL SERVICE EVERY 2 YEARS, AT THE LATEST. THE BATTERY MUST BE REPLACED SOONER IF IT CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF THE SYSTEM CANNOT BE OPERATED WITH THE FULLY CHARGED BATTERY. CHAPTER 5.6.1: BEFORE STARTING THE APPLICATION, CHECK THE POINTS LISTED IN "CHECK BEFORE EVERY USE". BEFORE EACH USE, ENSURE THAT THE BATTERIES ARE FULLY CHARGED. IF THE BATTERY CAPACITY IS LOW AN ACOUSTIC SIGNAL SOUNDS ON THE DEVICE. 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 THE US. CUSTOMER STATED THAT THE ROTAFLOW CONSOLE WAS RUNNING ON BATTERY FOR A SHORT PERIOD OF TIME. BATTERY VOLTAGE STARTED AT 28 VOLTS AND DROPPED TO 17 VOLTS AND SHUT DOWN WHILE ON A PATIENT WITHIN 5 MINUTES OF OPERATION. THE CUSTOMER USED THE HAND CRANK DURING USE. A PATIENT INCIDENT WAS REPORTED. NO MORE DETAILS ABOUT THE PATIENT INCIDENT WERE REPORTED. MORE INFORMATION ARE REQUESTED FOR THE PATIENT OUTCOME BUT STILL PENDING. THE DEVICE WAS CHECK BY A GETINGE FIELD SERVICE TECHNICIAN AND COULD NOT REPRODUCED THE REPORTED FAILURE. NEW INFORMATION REGARDING THE IMPACT FOR THE PATIENT HAS BEEN RECEIVED ON (B)(6) 2022 BY THE SSU (SALES AND SERVICE UNIT). PATIENT WAS MAINTAINED ON ECMO FOR ANOTHER 10 DAYS AND THEN EXPIRED. COMPLAINT: (B)(4).
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1389979 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | RFC 20-970 / ROTAFLOW CON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |