BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 15273232 · Received August 23, 2022

    Report

    Report Number
    8010762-2022-00331
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CLOSING ASSY OF THE ROTAFLOW 2 WAS USED ON A ROTAFLOW AND IS NOT PROPERLY FIXED AND CAME LOOSE DURING PATIENT TREATMENT. THE CUSTOMER WAS NEXT TO THE PATIENT AND COULD FIXATE THE PART AGAIN WITHOUT ANY HARM OCCURRING. A GETINGE SERVICE TECHNICIAN WAS ON SITE ON 2022-04-25 TO REPAIR THE AFFECTED ROTAFLOW (SERIAL#(B)(6). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND REPLACED THE RF2 (ROTAFLOW 2) DRIVE CLOSING COVER KIT (MATERIAL#701076073) WITH THE CORRECT RFD (ROTAFLOW DRIVE) CLOSING ASSY (MATERIAL# 70101.1680). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. AT MAQUET CARDIOPULMONARY IT WAS FOUND THAT THE CLOSING ASSY (MATERIAL# 701073911) FROM THE RF2 DRIVE CLOSING ASSY SET (MATERIAL# 701076073) DOES NOT FIT PERFECTLY ON THE RF DRIVE UNIT (MATERIAL# 701022161) OF THE ROTAFLOW (MATERIAL# 701051702) AND THEREFORE THE CLOSING ASSY DOES NOT CLOSE. THE INFORMATION REGARDING THE RF2 (ROTAFLOW 2) DRIVE CLOSING COVER KIT (MATERIAL#701076073) WILL BE HANDLED IN THE NON-CONFORMANCE PROCESS. THE COMPLAINT INFORMATION (INFORMATION REGARDING THE DRIVE CLOSING COVER KIT) WAS TRANSFERRED TO THE INTERNAL CP-SOP-003 NONCONFORMITY PROCESS (NC NO 3033131). FURTHER INVESTIGATIONS STEPS WILL BE DOCUMENTED IN THE NC NO 3033131. ON 2022-07-18 A SERVICE BULLETIN HAS BEEN SEND TO THE SALES AND SERVICE UNIT INFORMING THAT THE RF2 DRIVE CLOSING ASSY SET (MATERIAL# 701076073) IS NOT EQUIVALENT TO THE RFD (ROTAFLOW DRIVE) CLOSING ASSY (MATERIAL# 70101.1680). THIS MEANS, THAT THE SPARE PARTS ARE ONLY ALLOWED TO BE INSTALLED INTO THE DESIGNATED DRIVE AS A CLOSING ASSY. ON 2022-09-01 THE DECISION WAS MADE TO START A FSCA TO REPLACE THE RF2 DRIVE CLOSING COVER KIT (MATERIAL#701076073) THAT IS ALREADY INSTALLED WITH THE RFD CLOSING ASSY (MATERIAL# 70101.1680). A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON 2022-05-10 AND THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR COULD HAVE LED TO THE CUSTOMER COMPLAINT. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLOSING ASSY OF THE ROTAFLOW 2 USED AS A SPARE PART FOR THE ROTAFLOW 1 IS NOT PROPERLY FIXED AND CAME LOOSE DURING PATIENT TREATMENT. THE CUSTOMER REPLACED THE AFFECTED ROTAFLOW WITH A BACKUP DEVICE. NO PATIENT HARM OCCURRED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375256 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH RFD 20-973 ROTA FLOW DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention