BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 4894350 · Received July 1, 2015

    Report

    Report Number
    8010762-2015-00783
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT REQUESTED TO RETURN FOR MANUFACTURERS LABORATORY INVESTIGATION AS THE FAILURE IS KNOWN AND IS THOROUGHLY INVESTIGATED UNDER CAPA (B)(4). THE INVESTIGATION UNDER CAPA (B)(4) IDENTIFIED THAT THE FAILURE IS CAUSED BY TOLERANCE INTERFERENCES IN CURRENT DESIGN. MAQUET CARDIOPULMONARY WILL IMPLEMENT CORRESPONDING ACTION STEPS REGARDING THE DESIGN AND TOLERANCE CRITERIA'S OF THE DIALYSIS PORT. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS COMPLAINT WILL BE CLOSED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS A CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    TRANSLATED DESCRIPTION FROM THE CUSTOMER REPORT FROM GERMAN INTO ENGLISH: LEAKAGE OF PRIMING FLUID FROM DIALYSIS LOCK AND VALVE AT THE OXYGENATOR. ADDITIONAL COMMENT: CUSTOMER COMPLAINED 4 PRODUCTS WITH THIS MALFUNCTION IN THE RECEIVED COMPLAINT REPORT. BUT TIME OF INCIDENT AND LOT NUMBER WAS UNKNOWN AND COULD NOT BE MENTIONED BY THE CUSTOMER. FOR ALL 4 OXYGENATORS THE DESCRIBED MALFUNCTION WAS DETECTED DURING PRIMING. (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426397 HLM TUBING SET W/SOFTLINE COATING DTZ DTZ MAQUET CARDIOPULMONARY AG HQV 10803

    Patients

    Seq Age Sex Outcome Treatment
    1