BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9445714 · Received December 10, 2019

    Report

    Report Number
    0001526350-2019-01137
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Report Date
    December 10, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). 510(K) NUMBER: K101915 & K061814. PRODUCT REVIEW OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2019 REVEALED THAT THE DEVICE HAD PHYSICAL DAMAGE. ADDITIONAL PRODUCT EVALUATION WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2019 SINCE THE ORIGINAL EVALUATION PERFORMED ON (B)(6) 2019 DID NOT PROVIDE THE EXACT FAILURE OBSERVED DURING EVALUATION IS UNCLEAR. PRODUCT REVIEW PERFORMED ON (B)(6) 2019 REVEALED THAT THE DEVICE FRONT CASE WAS CRACKED ON BOTTOM AND BOTH SIDES, TUBING BETWEEN TIMING MOTOR AND HOSE CONNECTORS NOT PROPERLY SECURED TO TIMING MOTOR, POWER CORD WAS CUT AND WAS EXPOSING WIRES AND BATTERY WAS NOT RETURNED. REPAIR OF THE VP500DM VASOPRESS PUMP WAS NOT PERFORMED DUE TO THE DEVICE BEING SCRAPPED AFTER PRODUCT EVALUATION. THE REPORTED EVENT "THE DEVICE HAD CRACKED HOUSING" WAS CONFIRMED SINCE PRODUCT REVIEW PERFORMED ON (B)(6) 2019 REVEALED THAT THE DEVICE FRONT CASE WAS CRACKED ON BOTTOM AND BOTH SIDES. A DEFINITIVE ROOT CAUSE OF THE CRACKED HOUSING COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE CAUSE FOR THE FRONT CASE DAMAGE IS UNKNOWN. THE DEVICE WAS SCRAPPED AFTER EVALUATION. 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). THIS IS A WELL-KNOWN FAILURE MODE, WITH 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 UNIT HAD CRACKED HOUSING/ TRADE INS. THE PARTS ARE EXCHANGED A YEAR AGO AND DON'T RETURN. THERE WAS NO PATIENT IMPACT AND NO OUT OF BOX FAILURE. THE INVESTIGATION IDENTIFIED EXPOSED WIRES ON THE POWER CORD. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243318 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1