BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOVAC BLOOD REINFUSION SYSTEM 3/16

    MDR report key: 2903672 · Received January 4, 2013

    Report

    Report Number
    1526350-2013-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBE FOR WASTE FLUID OF THE ZIMMER HEMOVAC BLOOD REINFUSION SYSTEM CAME OFF OF THE Y-CONNECTOR AND WAS RECONNECTED. IT WAS NOTED THAT THE WASTE FLUID TUBE CAME OFF OF THE Y-CONNECTOR AGAIN AND WAS REINFORCED WITH TAPE. IT WAS REPORTED THAT AFTER SURGERY, THIS PRODUCT WAS USED AS A DRAIN. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4084 HEMOVAC BLOOD REINFUSION SYSTEM 3/16 HEMOVAC BLOOD REINFUSION SYSTEM 3/16 CAC ZIMMER SURGICAL NA 61341266

    Patients

    Seq Age Sex Outcome Treatment
    1