BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9078543 · Received September 17, 2019

    Report

    Report Number
    3002834373-2019-00001
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    September 10, 2019
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Product Code
    JOW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). (B)(4). PMA: 510K: K101915 & K061814. THERE WAS NO REPORTED PATIENT IMPACT WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR A REPAIR. AN INVESTIGATION OF THE PUMP WAS CONDUCTED AS PART OF THE REPAIR PROCESS BY THE REPAIR TECHNICIAN FOLLOWING THE STEPS IN AND COMPARING THE CONDITION AND PERFORMANCE OF THE PUMP TO THE KEY SPECIFICATIONS OF VP500DM REPAIR, DISASSEMBLY AND ASSEMBLY. THE PUMP WAS RETURNED IN A CONDITION CONSISTENT WITH BEING USED IN THE CLINICAL SETTING. THE ATTACHED REPAIR ROUTER CONTAINS SPECIFIC INFORMATION ABOUT THIS INVESTIGATION AND REPAIR INCLUDING: THE EXACT CONDITION OF THE PUMP WHEN RETURNED IN 'AS-RECEIVED INSPECTION' SECTION; RESULTS OF THE 'VISUAL INSPECTION' AND 'FUNCTIONAL INSPECTION' INCLUDING ANY OUT OF SPECIFICATION INFORMATION; ANY COMMENTS FROM THE REPAIR TECHNICIAN FROM THEIR INITIAL INSPECTION AND SUBSEQUENT REPAIR OF THE PUMP; THE REPAIR CODE(S); PARTS REPLACED; THE DATE THESE ACTIONS WERE ACCOMPLISHED AND OTHER DETAILS ABOUT THE REPAIR. THE ONLY SECTION OF DHR FOR THIS PUMP THAT WAS REVIEWED WAS THE REPAIR DOCUMENTATION BECAUSE THE PUMP WAS IN THE FIELD AND FUNCTIONING NORMALLY PRIOR TO THIS REPAIR. THIS COMPLAINT WAS NOT IDENTIFIED AS A COOB. THE REPORTED EVENT WAS NOT CONFIRMED SINCE THE DEVICE FUNCTIONED AS INTENDED DURING PRODUCT REVIEW. A ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED EVENT. THE PLUG MOLD IS A PART OF THE POWER CORD WHICH IS USED TO PLUG THE DEVICE INTO A AC POWER OUTLET. DAMAGE TO THE POWER CORD AND/OR PLUG MOLD CAN OCCUR BY THE CORD/PLUG MOLD BEING RUN OVER BY WHEELED EQUIPMENT OR BY THE CORD BEING PULLED FROM THE WALL OUTLET INADVERTENTLY. IN SOME CASES DAMAGE TO THE PRONGS, WIRE COVERINGS AND INSULATION MAY EXPOSE THE WIRES OF THE CORD WHEN EXCESSIVE FORCE IS APPLIED IN A CLINICAL SETTING. UNDER NORMAL CONDITIONS THE POWER CORD AND PLUG MOLD ARE NOT LIKELY TO BECOME DAMAGED. THE DAMAGE TO THE FRONT CASE, BACK CASE AND/OR HOSE SIDE PANEL COULD BE CAUSED BY DAMAGE DURING TRANSPORT, DROPPING OF THE DEVICE, THE PUMP BEING CRUSHED WHILE HANGING FROM THE BEDSIDE OR FROM GENERAL HANDING OF THE PRODUCT. THE CASE AND HOSE CONNECTOR PANEL ARE MADE FROM FLAME RETARDANT POLYMER. THE COMPONENTS ARE DIFFICULT TO DAMAGE IF USED AS INTENDED, MAKING IT UNLIKELY THAT THE CASE AND/OR HOSE SIDE PANEL FAILED DURING NORMAL USE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. THE REPORTED EVENT WAS NOT CONFIRMED SINCE THE DEVICE FUNCTIONED AS INTENDED DURING PRODUCT REVIEW; HENCE, A ROOT CAUSE CANNOT BE DETERMINED. THE PUMP WAS REPAIRED AND, AFTER SUCCESSFUL INSPECTION AND TESTING TO THE CURRENT REVISION OF VP500DM REPAIR, DISASSEMBLY AND ASSEMBLY BASED ON THE PUMP MODEL, RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WILL NOT PUMP UP. THERE WAS NO PATIENT IMPACT AS IT WAS FOUND DURING TESTING. INVESTIGATION REVEALED DAMAGE TO THE POWER CORD, EXPOSING WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873931 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW COMPRESSION THERAPY CONCEPTS, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1