BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BO-HQV 16403# HLM UNI. SET QUADROX

    MDR report key: 4142536 · Received October 1, 2014

    Report

    Report Number
    8010762-2014-00756
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG HAS NOT RECEIVED THE DEVICE FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER TEN MINUTES OF BY-PASS, DELTA P:280 MMHG FLOW WENT FROM 5.5L TO 0.5L. ACT WAS 450 AT THE ONSET OF PERFUSION. A COMPLETE TUBING SET WAS USED FOR THE EXCHANGE. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611578 BO-HQV 16403# HLM UNI. SET QUADROX TUBING SET WITH SOFTLINE COATING DWF MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1