BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9340289 · Received November 19, 2019

    Report

    Report Number
    0001526350-2019-01031
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). -DEVICE PRODUCT CODE- JOW UDI# - (B)(4). PMA/510(K) NUMBER - K101915 & K061814. PRODUCT REVIEW OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON JULY 24, 2019 REVEALED THAT THE POWER CORD WAS CUT AT STRAIN RELIEF. PER THE VERBAL COMMUNICATION WITH THE TECHNICIAN THE CORD HAD BEEN CUT JUST PAST THE PLUG MOLD AND THE WIRES WERE EXPOSED. BATTERY CONTACTS WERE ALSO CORRODED. REPAIR OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2019 INCLUDED REPLACEMENT OF POWER CORD AND BATTERY CONTACTS. VP500DM VASOPRESS PUMP, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT " THE DEVICE POWER CORD GOT CUT " WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE POWER CORD WAS CUT AT STRAIN RELIEF. PER THE VERBAL COMMUNICATION WITH THE TECHNICIAN THE CORD HAD BEEN CUT JUST PAST THE PLUG MOLD AND THE WIRES WERE EXPOSED A DEFINITIVE ROOT CAUSE OF THE CUT POWER CORD COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN WHAT CAUSED THE DAMAGE TO THE POWER CORD. THE POWER CORD WAS REPLACED. 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. 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 AS A PRODUCT RETURN WITH NO ADDITIONAL DETAIL. UPON REPAIR OF THE PRODUCT, IT WAS REPORTED THAT THE POWER CORD GOT CUTS IN THE UNIT. IT WAS CONFIRMED THAT THERE WERE EXPOSED WIRES. THERE WAS NO PATIENT IMPACT AND NO OUT OF BOX FAILURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140180 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1