BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED TOURNIQUET CUFF

    MDR report key: 6088194 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00031
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    KCY
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND WE CONFIRMED THAT IT WAS A MEDLINE RENEWAL REPROCESSED ZIMMER TOURNIQUET CUFF, MODEL 60-7075-106. WE PERFORMED A THOROUGH INSPECTION AND INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION THAT THE TOURNIQUET IN QUESTION PASSED THE INTERNAL LEAK TEST PERFORMED BY MEDLINE RENEWAL AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN AT THIS TIME. ALTHOUGH NO PATIENT HARM, MEDICAL INTERVENTION OR DELAY IN THE PROCEDURE WAS REPORTED, DUE TO THE REPORTED IMPACT TO VISIBILITY DURING USE, MEDLINE RENEWAL IS FILING THIS MEDWATCH IN AN ABUNDANCE OF CAUTION. THIS MEDWATCH REPORT WAS ORIGINALLY SUBMITTED ON 10/28/2016, HOWEVER DUE TO AN INTERNAL ERROR, THIS REPORT WAS SUBMITTED THROUGH THE ESG TEST ACCOUNT INSTEAD OF THE ESG PRODUCTION ACCOUNT. CONSEQUENTLY, CDRH DID NOT RECEIVE THIS REPORT WITHIN THE 30 DAY TIMEFRAME. THEREFORE, THIS MEDWATCH REPORT NOW REFLECTS TODAY'S DATE WHICH CORRESPONDS WITH THE FILE TRANSMISSION THROUGH THE ESG PRODUCTION ACCOUNT.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING A REPROCESSED ZIMMER TOURNIQUET CUFF, MODEL 60-7075-106, WOULD NOT STAY INFLATED DURING A TOTAL KNEE REPLACEMENT PROCEDURE. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN PATIENT HARM, HOWEVER VISIBILITY WAS IMPACTED. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE. THEREFORE NO PATIENT HARM, PROCEDURAL DELAY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736625 MEDLINE RENEWAL REPROCESSED TOURNIQUET CUFF PNEUMATIC TOURNIQUET KCY MEDLINE RENEWAL 60-7075-106 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention