BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GI SUPPLY LARGE VOLUME PARACENTESIS KIT

    MDR report key: 6093892 · Received November 10, 2016

    Report

    Report Number
    2529592-2016-00003
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 27, 2016
    Manufacturer
    GI SUPPLY
    Product Code
    LRO
    PMA / PMN Number
    K970187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY THAT REPORTED THE INCIDENT USED THE RENOVA RP PARACENTESIS PUMP WITH THE SINGLE USE LARGE VOLUME PARACENTESIS KIT ON THE PATIENT BEFORE THE INCIDENT OCCURRED AND HAD NO ISSUES. THE DESCRIPTION PROVIDED IS THAT THE TUBING BEGAN TO SPRAY FROM THE CONNECTOR BETWEEN THE LARGER DIAMETER TUBING SECTION AND SMALLER DIAMETER TUBING ON THE RIGHT SIDE OF THE PUMP HEAD (EXITING THE PUMP HEAD). THE NURSE WAS SPRAYED WITH FLUID. THE PUMP WAS TURNED OFF AND TUBING WAS REMOVED. A NEW KIT WAS OPENED AND THE PROCEDURE WAS RESUMED WITHOUT INCIDENT. A PICTURE OF THE KIT IN THE PUMP WAS SENT TO THE NURSE TO IDENTIFY EXACTLY WHERE THE TUBING CAME APART. THE LARGE VOLUME PARACENTESIS KIT WITH THE ISSUE OF THE TUBING COMING APART WAS DISCARDED BY THE NURSE. THE DESCRIPTION OF THE ISSUE ALONG WITH THE PICTURES HAS BEEN SENT TO THE CONTRACT MANUFACTURER FOR INVESTIGATION. AN INTERIM NOTICE FROM THE CONTRACT MANUFACTURER HAS BEEN RECEIVED WHERE IMMEDIATE ACTIONS WERE TAKEN TO TEST THE AFFECTED LOT NUMBER RETAINS FOR TUBING JOINT PULL TEST, TO PULL RANDOM SAMPLES & PERFORM TUBING JOINT PULL TEST ON REMAINING INVENTORY OF AFFECTED LOT NUMBER AND TO PERFORM DHR REVIEW ON AFFECTED LOT NUMBER. NO PRODUCT TEST FAILURES OR DISCREPANCIES WERE FOUND. GI SUPPLY PERFORMED A QA/QC REVIEW OF THE TESTING PERFORMED AT INCOMING INSPECTION. THE TESTING INCLUDES VERIFYING THE INTEGRITY OF THE TUBING SET AND A LEAK TEST WHILE THE KIT IS CONNECTED TO THE PUMP. ALL TESTING MET SPECIFICATIONS. ADDITIONAL TESTING ON FIVE RETAINS WAS PERFORMED BY TESTING THE TUBING AS SIMILAR FLUID WAS RUN THROUGH THE PUMP. ALL TESTING WAS DESIGNED AND PERFORMED BASED ON THE COMPLAINT ISSUE DESCRIBED. NO INSTANCES OF LEAKAGE OR SEPARATION WERE OBSERVED DURING THE TESTING. THIS APPEARS TO BE AN ISOLATED MANUFACTURING INCIDENT. CORRECTIVE ACTION HAS BEEN REQUESTED TO THE CONTRACT MANUFACTURER. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED ON 30 SEPTEMBER 2016. THE ISSUE OCCURRED WHEN THE USER, A NURSE, WAS PERFORMING THE PARACENTESIS FLUID REMOVAL ON A PATIENT USING THE LARGE VOLUME PARACENTESIS KIT IN CONJUNCTION WITH THE RENOVARP PARACENTESIS PUMP. DURING THE PROCEDURE, THE TUBING BEGAN TO SPRAY FROM THE CONNECTOR BETWEEN THE LARGER DIAMETER TUBING SECTION AND THE SMALLER DIAMETER TUBING ON THE RIGHT SIDE OF THE PUMP HEAD (EXITING THE PUMP HEAD). THIS RESULTED IN THE USER BEING EXPOSED TO THE PATIENT'S BODY FLUID. THE USER CONFIRMED THERE WAS NO INJURY BUT SINCE THE USER INDICATED THAT SHE WAS EXPOSED TO THE FLUID, THE INCIDENT IS BEING REPORTED DUE TO THE EXPOSURE TO THE PATIENT'S BODY FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743891 GI SUPPLY LARGE VOLUME PARACENTESIS KIT PARACENTESIS KIT, PRODUCT CODE: LRO LRO GI SUPPLY VL503652

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other