BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 15215914 · Received August 12, 2022

    Report

    Report Number
    8010762-2022-00323
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 27, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HL20 PUMP DISPLAYED THE ERROR MESSAGE: "BELT SLIP". NO HARM TO ANY PERSON WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN WILL BE SENT ONSITE FOR AN INVESTIGATION. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT TO COMPLAINT 675319 WHICH WAS REPORTED UNDER MFR#8010762-2022-00323, WHICH IS A DUPLICATE ENTRY TO COMPLAINT #675701, REPORTED UNDER MFR#8010762-2022-00325 ON 2022-08-14.

    Additional Manufacturer Narrative · 0

    CORRECTION OF PRODUCT CODE. THE COMPLAINT WAS SUBMITTED UNDER PRODUCT CODE "DAA" HOWEVER THE CORRECT PRODUCT CODE SHOULD BE "DTQ". THE DEVICE CAN BE IDENTIFIED BASED ON THE MATERIAL- AND SERIAL NUMBER OF THE PRODUCT, THEREFORE NO UDI WILL BE LISTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HL20 PUMP DISPLAYED THE ERROR MESSAGE: "BELT SLIP". NO HARM TO ANY PERSON WAS REPORTED. REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    REF# (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707371 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20
    2299191 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown