BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4737022 · Received April 27, 2015

    Report

    Report Number
    8010762-2015-00407
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 30, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. SIMILAR PRODUCTS, 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 INFO: 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: "DURING PRIMING PROCEDURE, THE MEASURED VENOUS PRESSURES RANGED BETWEEN -400MMHG AND 800MMHG. AS THE PT WAS INSTABLE, CUSTOMER DECIDED NOT USING THE SYSTEM WITHOUT RELIABLE PRESSURE MEASUREMENT. CUSTOMER REASSURES THAT NO FLUID HAS ENTERED IN THE SOCKET DURING AIR-ELIMINATING." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277062 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-HLS 7050 701022848

    Patients

    Seq Age Sex Outcome Treatment
    1