BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-HQV 70600#ADULT PACK

    MDR report key: 4684283 · Received April 9, 2015

    Report

    Report Number
    8010762-2015-00349
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SEND AFTER RECEIVING FURTHER INFORMATION. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510 (K) : K102919.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "TEMPERATURE PROVE AT VENOUSE INLET IS NOT TIGHT. AIR IS CONSTANTLY SUCKED INTO VENOUS RESERVOIR. THEY REMOVE TERPERATURE PROBE AND REPLACE IT WITH A PLUG FROM TOP OF RESERVOIR. PROBLEM IS NOT SOLVED. IT SEEMS THE PROBLEM IS NOT THE TEMPERATURE PROBE, BUT THE FEMALE LL IN WHICH THE PROBE IS INSERTED!?" IT TOOK PLACE DURING PATIENT TREATMENT, NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233561 BO-HQV 70600#ADULT PACK DWE MAQUET CARDIOPULMONARY AG BO-HQV 70600

    Patients

    Seq Age Sex Outcome Treatment
    1