BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-HQV 70600 ADULT PACK

    MDR report key: 4921174 · Received July 15, 2015

    Report

    Report Number
    8010762-2015-00810
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS WITH SIMILAR MALFUNCTION. DUE TO THIS WE TAKE THESE COMPLAINTS AS AN INPUT TO START AN INTERNAL PROJECT WITH THE INTENTION TO REVIEW ASPECTS OF THE DESIGN, THE MFG PROCESS AND THE TEST METHODS. THIS REVIEW SHOULD COVER ALL POSSIBLE IMPACTS OF THE QUALITY THE VHK71000 RESERVOIR. ADDITIONAL INFO: THE PRODUCT MENTIONED 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: "USER OBSERVED AN AIR LEAKAGE ON THE HEAT PROBE WHICH IS PLACED IN VENOUS LINE OF THE OXYGENATOR. PROBLEM WAS CONTINUED EVEN THOUGH THE USER HAD DONE ESSENTIAL ACTIONS. NON-CONFORMITY WAS OBSERVED ALMOST AT THE END OF THE SURGERY, AND THE QUESTIONED PRODUCT WAS NOT REPLACED WITH A NEW ONE. NO HARM OCCURRED IN THE PT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460888 BO-HQV 70600 ADULT PACK DTN MAQUET CARDIOPULMONARY AG VKMO 71000 92131225

    Patients

    Seq Age Sex Outcome Treatment
    1