BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GI SUPPLY LARGE VOLUME PARACENTESIS KIT

    MDR report key: 5867190 · Received August 10, 2016

    Report

    Report Number
    2529592-2016-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 10, 2016
    Manufacturer
    GI SUPPLY
    Product Code
    LRO
    PMA / PMN Number
    K970187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 SEPARATED FROM THE BIGGER SECTION THAT IS PLACED IN THE PUMP ROLLERS AND THE SMALLER SECTION THAT FLOWS TO THE BAG. A PICTURE OF THE KIT IN THE PUMP WAS SENT TO THE NURSE TO IDENTIFY EXACTLY WHERE THE TUBING CAME APART. THE NURSE SUBSEQUENTLY OPENED ANOTHER KIT AND NO ISSUES WERE OBSERVED. 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. 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. THIS ISSUE HAS NOT BEEN PREVIOUSLY REPORTED AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT OR THIS ISSUE AS OF 10-AUGUST-2016. THE CONTRACT MANUFACTURER'S INVESTIGATION HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED ON (B)(6) 2016. THE ISSUE OCCURRED WHEN THE USER, A NURSE, WAS REMOVING ASCITIC FLUID FROM THE ABDOMINAL CAVITY USING THE LARGE VOLUME PARACENTESIS KIT IN CONJUNCTION WITH THE RENOVARP PARACENTESIS PUMP. DURING THE PROCEDURE, THE TUBING SEPARATED WHILE CONNECTED TO THE PUMP RESULTING IN THE USER BEING EXPOSED TO THE PATIENT'S ASCETIC 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
    519136 GI SUPPLY LARGE VOLUME PARACENTESIS KIT PARACENTESIS KIT LRO GI SUPPLY 61500374

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other