BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL PUMP

    MDR report key: 9370201 · Received November 25, 2019

    Report

    Report Number
    0001526350-2019-01070
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    July 18, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K061814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). DEVICE PRODUCT CODE: JOW. (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE VP500D VASOPRESS PUMP WITH SERIAL NUMBER (B)(4) 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. PRODUCT REVIEW OF THE VP500D VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2019 REVEALED THAT THE POWER CORD WAS CUT AND THE WIRES WERE EXPOSED, THE DEVICE DID NOT TURN AND COULD NOT BE TESTED. REPAIR OF THE VP500D VASOPRESS PUMP WAS NOT PERFORMED BY ZIMMER BIOMET SURGICAL DUE TO THE DEVICE BEING SCRAPPED AFTER PRODUCT EVALUATION. THE REPORTED EVENT "THE DEVICE WAS DELIVERING INCORRECT PRESSURE" WAS NOT CONFIRMED SINCE DURING PRODUCT REVIEW THAT THE POWER CORD WAS CUT AND THE WIRES WERE EXPOSED, THE DEVICE DID NOT TURN AND COULD NOT BE TESTED. A DEFINITIVE ROOT CAUSE OF THE INCORRECT PRESSURE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE REPORTED EVENT WAS NOT CONFIRMED DURING EVALUATION OF THE DEVICE AS THE DEVICE COULD NOT BE TESTED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THE COMPLAINT WAS NOT CONFIRMED AND THERE WAS NO ALLEGATIONS OF HARM OR INJURY THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS DELIVERING INCORRECT PRESSURE. DURING INVESTIGATION, IT WAS DISCOVERED THAT THERE WAS EXPOSED WIRING ON THE DEVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168277 VASOPRESS DIGITAL PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1