BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    34IN. (86CM) DISPOSABLE CUFF W/PLC - SP, SB

    MDR report key: 8343689 · Received February 15, 2019

    Report

    Report Number
    0001526350-2019-00109
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    October 5, 2018
    Report Date
    April 1, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D10, G4, G7, H2, H3, H6 AND H10. D4 - UDI# - (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFF WITH PLC, PART NUMBER 60707510600 AND LOT NUMBER Z000006310, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 22 JAN 2019, IT WAS REPORTED FROM MEDLINE INDUSTRIES, INC. THAT FOUR 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFFS WITH PLC WERE LEAKING. THE CUFFS WERE FULLY INFLATED AND AFTER AN HOUR THEY WERE SLIGHTLY DEFLATED. ON 18 FEB 2019, A RETURNED PRODUCT INVESTIGATION WAS PERFORMED ON THE 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFFS WITH PLC. THE PHYSICAL EVALUATION REVEALED THAT THE RETURNED CUFFS ALL HAD A LEAK, TRIGGERING A CUFF LEAK DETECTED ERROR. THE LEAKS OBSERVED APPEAR TO BE COMMON TO THE AREA WHERE THE TUBING CONNECTS WITH THE CUFF. THE RESULTS OF THE RETURNED PRODUCT INVESTIGATION HAVE CONFIRMED THE REPORTED EVENT. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFFS WITH PLC WERE LEAKING, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE CUSTOMER HAS INDICATED THAT THE DEVICE IS IN PROCESS OF RETURNING TO THE MANUFACTURER FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED SEVEN TOURNIQUETS THAT WERE LEAKING. THE TOURNIQUETS WERE FULLY INFLATED AND LEFT ALONE FOR AN HOUR; AFTER THE HOUR THE TOURNIQUETS WERE SIGNIFICANTLY DEFLATED WITH ONE END SEALED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137734 34IN. (86CM) DISPOSABLE CUFF W/PLC - SP, SB TOURNIQUET, PNEUMATIC KCY ZIMMER SURGICAL, INC. Z000006876

    Patients

    Seq Age Sex Outcome Treatment
    1