BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4927904 · Received July 17, 2015

    Report

    Report Number
    8010762-2015-00820
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. SIMILAR COMPLAINTS SHOWING THE SAME MALFUNCTION HAVE BEEN INVESTIGATED AND AN OXIDIZED PRESSURE SENSOR WAS FOUND, THIS COULD BE THE MOST PROBABLE CAUSE FOR THE FAILURE. AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K): K101153.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "CUSTOMER STATES THEY HAD AN HLS SET PRIMED FOR TWO WEEKS. WHEN ATTEMPTING TO USE, VENOUS LINE PRESSURES WERE +400-500MMHG AND AFTER RE-ZEROING, -400-500MMHG. CUSTOMER DECIDED TO USE ANOTHER HLS SET RATHER THAN THE ONE THAT HAD BEEN SET UP FOR TWO WEEKS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465897 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1