BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10654414 · Received October 9, 2020

    Report

    Report Number
    8010762-2020-00333
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 23, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOPLEGIA MONITOR WAS NOT WORKING. AS STATED BY THE SSU INDIA VIA EMAIL COMMUNICATION ON 2020-11-10 THE PROBLEM WAS RESOLVED BY REPLACING THE CARDIOPLEGIA MONITOR UNIT (CMU). THE PRODUCT IN QUESTION WAS PRODUCED IN 2013-07-18. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2013-07-18 TO 2020-11-23 DOES 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 CAN BE EXCLUDED THE REPORTED FAILURE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE DEFECTIVE CMU (CARDIOPLEGIA MONITOR UNIT) COULD NOT BE DETERMINED. IT IS UNKNOWN WHEN THE EVENT OCCURRED, WAS THE DEVICE BEING USED FOR TREATMENT OF THE PATIENT 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 · 0

    COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WA REPORTED THAT THE CARDIOPLEGIA MONITOR WAS NOT WORKING. COMPLAINT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120599 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1