BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOVAC BLOOD REINFUSION SYSTEM

    MDR report key: 2860160 · Received November 21, 2012

    Report

    Report Number
    1526350-2012-00301
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL. PICTURES OF THE DEVICE WERE PROVIDED BY THE HOSPITAL AND THE MATERIALS SEEN WITHIN THE PICTURE APPEARS TO BE FATS WITHIN THE BLOOD. THERE WAS SOME SPECULATION AS TO WHETHER THIS MATERIAL WAS GELFOAM. SINCE THE DEVICE WAS NOT RETURNED THIS CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE HAVE INSTRUCTIONS THAT ADDRESS THE CUSTOMER'S QUESTION OF WHETHER THE BLOOD CAN BE REINFUSED. THE INSTRUCTIONS STATE THAT AN AMOUNT OF BLOOD WILL REMAIN WITHIN THE CANISTER AFTER TRANSFER AND THAT THIS FLUID MAY CONTAIN FATS AND SHOULD NOT BE REINFUSED. THE INSTRUCTIONS WARN AGAINST USING PRESSURE TO REINFUSED. THE INSTRUCTIONS WARN AGAINST USING PRESSURE TO REINFUSE THE BLOOD. THE USER IS REQUIRED TO PREPARE A STANDARD ADMINISTRATION SET WITH A 20 OR 40 MICRON MICROAGGREGATE FILTER FOR BLOOD REINFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A ZIMMER HEMOVAC BLOOD REINFUSION SYSTEM, A WHITE SUBSTANCE WAS FOUND IN THE CANISTER. ACCOUNT ASSUMES IT TO PROBABLY BE GELFOAM. THE GELFOAM IS USED TO STOP BLEEDING. IT CLOGGED THE SYSTEM AND CLOTS THE BLOOD. IT WAS ALSO REPORTED THAT THE WHITE SUBSTANCE GOT STUCK IN THE DRAIN. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT GELFOAM OR OTHER HEMOSTATIC AGENT HAD NOT BEEN USED. THE SALVAGE BLOOD WAS NOT TRANSFUSED. IT IS UNK WHY THE SALVAGE BLOOD WAS STATED TO HAVE NOT BEEN TRANSFUSED. SINCE THE INTENDED FUNCTION OF THE PRODUCT IS TO RETAIN ANY COLLECTED FAT FROM TRANSFERRING TO THE RE-INFUSION BAG. THERE WAS NO HARM OR DELAY OF THE PLANNED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOVAC BLOOD REINFUSION SYSTEM NONE CAC ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1