BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5317621 · Received December 22, 2015

    Report

    Report Number
    8010762-2015-01273
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 2, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT REQUESTED TO RETURN TO MANUFACTURER FOR LABORATORY INVESTIGATION AS THE FAILURE IS ALREADY KNOWN TO THE MANUFACTURER AND HAS BEEN THOROUGHLY INVESTIGATED UNDER A PREVIOUS COMPLAINT. THEREBY A VISUAL INSPECTION WAS PERFORMED AND A BROKEN BLOOD OUTLET CONNECTOR COULD BE CONFIRMED. THE OUTER (PRIMARY AND SECONDARY) PACKAGING OF THE PRODUCT WAS VISUALLY INSPECTED AND SEVERAL DAMAGES WERE FOUND. THE MOST PROBABLE CAUSE OF THE FAILURE FOUND IS EXCESSIVE PHYSICAL FORCE DURING TRANSPORT. BASED ON THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET / VKMO AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "CUSTOMER FIND THE BLOOD OUTLET WAS BROKEN WHEN THEY OPEN THE PACKAGE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845419 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92151329

    Patients

    Seq Age Sex Outcome Treatment
    1