BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10000401 · Received April 27, 2020

    Report

    Report Number
    8010762-2020-00140
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 23, 2020
    Report Date
    July 22, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN THE REPORTED FAILURE "DRIVE DOES NOT SPIN UP" OCCURRED IS UNKNOWN. THE DEVICE WAS DIRECTLY INVOLVED AND NOT ABLE TO MEET ITS SPECIFICATIONS. THE FAILURE COULD BE CONFIRMED. THE AFFECTED ROTAFLOW DRIVE WAS SENT BACK UNDER RMA#40952 FOR INVESTIGATION/REPAIR BY THE MANUFACTURER EMTEC. DRIVE RECEIVED IN RASTATT: 2020-06-04 FUNCTIONALITY TEST IN RASTATT: 2020-06-18-->FAILURE COULD BE CONFIRMED. SEND TO EMTEC: 2020-06-24 BACK FROM EMTEC: 2020-07-20 FUNCTIONALTEST AFTER EMTEC: 2020-07-21. ACCORDING TO THE SERVICE REPORT RMA2020-10223 DATED ON 2020-07-09 THE REPORTED FAILURE"DRIVE DOES NOT SPIN UP" COULD BE REPRODUCED. NO ERRORS WERE SHOWN ON THE CONSOLE. FOLLOWING WORK HAS BEEN PERFORMED BY EMTEC: -ELECTRONIC PARTY MC1 AND MC2 HAVE BEEN REPLACED. -CONTROL CABLE HAS BEEN REPLACED. -SEAL ON BLOACK HAS BEEN REPLACED. - ROTAFLOW DRIVE PASSED ALL TESTS. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED ACCORDING TO EMTEC AS AGING. ACCORDING TO THE SERVICE REPORT 10478348 DATED ON 2020-07-21 THE ROTAFLOW DRIVE WAS TESTED ACCORDING TO THE CURRENT SERVICE PROTOCOL. 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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FLOW MEASUREMENT IS NOT DISPLAYED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463534 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH 701022161 - ROTAFLOW DRIVE UNIT, BLUE

    Patients

    Seq Age Sex Outcome Treatment
    1