BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUUM PUMP

    MDR report key: 1712686 · Received June 4, 2010

    Report

    Report Number
    8030949-2010-00001
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BIOMET CEMENTING TECHNOLOGIES AB
    Product Code
    JDZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. PATIENT WAS NOT INJURED OF EFFECTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPERIMENTAL TESTING OF THE RETURNED VACUUM PUMP AND SIMULATION OF MALFUNCTION SITUATIONS FOUND THAT THE SITUATION REPORTED CAN ONLY BE CREATED IN A LOW PRESSURE SITUATION. IT WAS FOUND THAT A PART IN THE PUMP ASSEMBLY WAS DISLOCATED DUE TO AN INADEQUATE LOCKING EFFECT OF THE PARTS. THIS AFFECTED THE AIR FLOW WITHIN THE PUMP CREATING A PRESSURE INSTEAD OF THE ANTICIPATED VACUUM EFFECT. MANUFACTURING HISTORY WAS REVIEWED WITH NO DEVIATIONS OR ABNORMALITIES. ALL (100%) OF THE VACUUM PUMPS ARE TESTED PRIOR TO FINAL PRODUCT RELEASE FOR VACUUM EFFECT. COMPLAINT HISTORY FOUND ONE RELATED COMPLAINT WHERE THE VACUUM EJECTOR HAD LOOSENED, AND THREE COMPLAINTS WHERE THE CONNECTOR WAS NOT TIGHTENED ENOUGH, BUT NONE OF THE COMPLAINTS CAUSED ANY TYPE OF BURSTING EFFECT. DUE TO THIS BEING A REUSABLE PRODUCT, IT CANNOT BE DETERMINED THAT THE ITEM WAS IN THIS CONDITION WHEN IT WAS INITIALLY RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE SURGERY ON (B) (6) 2010, THE BONE CEMENT VACUUM PUMP WAS PUT IN THE "ON" POSITION, WHEN THE MONOMER FROM ALUMINUM POUCHES BURST, CAUSING LIQUID AND POWDER TO LAND ON THE CLOTHES, SKIN AND GET IN THE EYES OF A NURSE. THE NURSE FLUSHED HER EYES WITH WATER WITH NO FURTHER COMPLICATIONS. ANOTHER VACUUM PUMP WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUUM PUMP JDZ BIOMET CEMENTING TECHNOLOGIES AB NA 6606

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention