BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 9994552 · Received April 24, 2020

    Report

    Report Number
    8010762-2020-00135
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    April 8, 2020
    Report Date
    April 22, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE WAS BELTS SLIPPING RESULTING IN HEAD ERROR. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ONSITE AND INVESTIGATED THE UNIT IN QUESTION. ACCORDING TO SERVICE ORDER # (B)(4) DATED ON (B)(6) 2020 FOLLOWING WORKS HAS BEEN DONE: FOUND THE BELTS NEEDED REPLACED. PREVENTIVE MAINTENANCE, CALIBRATION CHECK, FULL FUNCTIONAL TEST AND SAFETY CHECK AS PER THE SERVICE MANUAL. ALL TESTS PASSED. AS STATED BY THE SSU VIA COMMUNICATION FIELD ON 2020-04-20 THE BELTS WEREN'T DUE UNTIL JULY 2020. DURING MEASURING OF THE BELT TENSION THE ONE BELT COULD NOT BE ADJUSTED ANY TIGHTER AND WAS WAY OUT OF SPEC.(SPEC WAS 900-970 HZ AND IT WAS READING 570 HZ) SO BOTH BELTS WERE REPLACED AND NOTED THE DATE FOR THE BELT REPLACEMENT. THE BELTS SLIPPING CAUSED THE ERROR MESSAGE. THE OLD BELTS IS NOT AVAILABLE ANYMORE BECAUSE THE SERVICE MANUAL SAYS TO CUT THE BELTS FROM THE OLD PULLEYS. THUS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE "HEAD ERROR" MESSAGE COULD BE DETERMINED AS BELTS SLIPPING. THE BELT TENSION WAS OUT OF SPEC. AND COULD NOT BE ADJUSTED. THE REPORTED FAILURE "HEAD ERROR" HAPPENED DURING PATIENT TREATMENT. THE HL20 IN QUESTION WAS RESPONSIBLE FOR THIS COMPLAINT/EVENT. 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 · 1

    IT WAS REPORTED THAT THE UNIT EXHIBITED BELT SLIP/ HEAD ERROR MESSAGE DURING PUMPING, THEN UNIT QUIT PUMPING. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460008 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH 701035075 - HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1