BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4780852 · Received May 15, 2015

    Report

    Report Number
    8010762-2015-00460
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ADD'L 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 VENOUS PRESSURE WAS NOT READING, INITIALLY I READ A NUMBER AND THEN STOPPED READING. THEY CHANGED THE INTEGRATED SENSOR WITH NO BENEFIT, SO REPLACED THE DISPOSABLE. NO PT INVOLVEMENT". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320600 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BEQ-HLD 5050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1