BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5086776 · Received September 18, 2015

    Report

    Report Number
    8010762-2015-01050
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 22, 2015
    Report Date
    August 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    SEPTEMBER 17, 2015 10:10 AM (GMT-4:00) ADDED BY (B)(6): (B)(4). THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). 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

    IT WAS REPORTED THAT DURING INITIATION OF THE ROOM THE CARDIHELP PRESSURE TRANSDUCER FUNCTION FAILED TO WORK APPROPRIATELY. ATTEMPTS TO RE-ZERO AND A CONSOLE EXCHANGE DID NOT SOLVE THE PROBLEM. IT WAS DETERMINED THAT THE DISPOSABLE (PRESSURE STRIP) WAS NOT WORKING. THE PATIENT WAS NOT STABLE ENOUGH AT THE TIME TO UNDERGO A CIRCUIT CHANGEOUT. THERE WAS A NON-STERILE DISPOSABLE CONNECTED TO THE PRESSURE CABLE TO PREVENT CONTINUOUS ALARMING. THE SATURATION/HB PROBE WAS FULLY FUNCTIONING. THE DEVICE WAS NOT REPLACED AND THERAPY WAS EVENTUALLY DISCONTINUED. NO REPORTED PATIENT EFFECT OR DELAY IN THERAPY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618790 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG 70105.2794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| R