BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HQV 51100#ADULT PRE-CONNECTED PACK

    MDR report key: 4543734 · Received February 23, 2015

    Report

    Report Number
    8010762-2015-00107
    Event Type
    Injury
    Date Received
    February 23, 2015
    Date of Event
    January 23, 2015
    Report Date
    January 25, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K001787
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION HAVE BEEN TESTED. TIGHTNESS TESTING HAS BEEN PERFORMED ON THE SAMPLE. LEAKAGE BETWEEN HOUSING AND COVER COULD BE CONFIRMED. THE MOST PROBABLE ROUTE-CAUSE IS POOR GLUE CONNECTION AT THE HOUSING. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER IS A TUBING SET WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUART FILTER) IS REGISTERED UNDER 510(K): 5001787. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A LEAK WAS NOTED COMING FROM THE QUART FILTER IN THE CIRCUIT. IT APPEARED TO BE IN THE VICINITY OF THE BYPASS LOOP MECHANISM. THE LEAKING UNIT WAS CUT OUT AND REPLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125653 HQV 51100#ADULT PRE-CONNECTED PACK QUART ATERIAL FILTER DTM MAQUET CARDIOPULMONARY AG 92142463

    Patients

    Seq Age Sex Outcome Treatment
    1