BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3876888 · Received June 17, 2014

    Report

    Report Number
    0001056128-2014-00073
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. AS THE REPORTED COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION, VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION/TESTING COULD NOT BE PERFORMED. AS THE COMPLAINT DEVICE WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. THE STRYKER SUSTAINABILITY SOLUTIONS IFU FOR REPROCESSED TOURNIQUET CUFFS STATES: "INSPECT THE DEVICE FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE DEVICE IF ANY DAMAGE IS NOTED. RETURN THE DEVICE AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY." THE LOT CONTROL SHEET FOR THE COMPLAINT DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT IS BEING FILED DUE TO SIGNIFICANT BLOOD LOSS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "80 MINUTES AFTER TOURNIQUET INFLATION, THERE WAS A SIGNIFICANT AMOUNT OF BLOOD IN ONTO THE SURGICAL FIELD. THE TOURNIQUET MACHINE DID NOT INDICATE LOSS OF PRESSURE AND NO ALARMS SOUNDED, BUT IT APPEARED IT HAD LOST PRESSURE." NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356066 NA TOURNIQUET, PNEUMATIC KCY STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 60-7070-106 2896659

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other