BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED INFUSION 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK

    MDR report key: 6172469 · Received December 13, 2016

    Report

    Report Number
    1723533-2016-00177
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    January 29, 2015
    Report Date
    January 29, 2015
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K873961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADMINSTRATION SET IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR EVALUATION. THE SAMPLE WAS SUBMERGED UNDER WATER, AIR PRESSURE AT 5 PSI WAS APPLIED, AND A LEAK WAS CONFIRMED AT THE SAMPLE'S PRESSURE CELL. THERE WERE NO OBSERVED DEVIATIONS WHILE REVIEWING THE MANUFACTURING RECORDS FOR THIS DEVICE'S LOT. WALKMED INFUSION WAS UNABLE TO CONFIRM THE DEFECT WAS A RESULT OF THE MANUFACTURING PROCESS AND NO ROOT CAUSE WAS IDENTIFIED. HOWEVER, A 100% INSPECTION OF THE PRESSURE CELL'S DIAPHRAGM WAS IMPLEMENTED IN THE MANUFACTURING PROCESS OF THIS PRODUCT.

    Description of Event or Problem · 1

    A PATIENT WAS SENT HOME WITH AN AMBULATORY PUMP, AN ADMINISTRATION SET, AND A RESERVOIR BAG FILLED WITH MEDICATION. IN THE MIDDLE OF THE NIGHT, THE PATIENT OBSERVED MEDICATION HAD LEAKED AND THE TUBE SET HAD BLOOD BACK UP. THE PATIENT OBSERVED THEIR HAND WAS EXPOSED TO 5FU AND CLEANED IT WITH SOAP AND WATER, AND CLAMPED THE TUBE SET. WHEN THE PATIENT ARRIVED AT THEIR CLINIC, THE NURSE DID NOT OBSERVE ANY INJURIES AND MEDICAL INTERVENTION WAS NOT PERFORMED. THE NURSE DID OBSERVE THE CARRYING CASE WAS COVERED IN DRIED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820771 WALKMED INFUSION 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK INTRAVASCULAR ADMINSTRATION SET FPA WALKMED INFUSION, LLC. 2044500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WALKMED INFUSION IPR-250 RESERVOIR BAG| WALKMED INFUSION WM350VL INFUSION PUMP