BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 514816 · Received February 25, 2004

    Report

    Report Number
    MW1031344
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    February 3, 2004
    Report Date
    February 25, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED TO SOLUMEDROL GRAVITY INFUSION. THEY CALLED NURSE WITHIN 10 MINUTES SAYING TUBING WAS LEAKING. NURSE FOUND LEAKING UNDER THE ROLLER CLAMP. THERE WERE VISIBLE TEETH MARKS FROM ROLLER CLAMP, HAD ERODED THROUGH THE TUBING. THE TUBINGS ARE USED FOR 48 HRS PER HOMECARE PROTOCOL. PT WAS CONNECTED TO SOLUMEDROL 1 GM OVER 2 HRS VIA THE GRAVITY BAXTER TUBING THE DAY BEFORE. AFTER THAT WAS COMPLETED - TUBING WAS CLOSED AND DISTAL END CAPPED TO MAINTAIN INTEGRITY. THE LEAKING WAS NOTED WITH THE SECOND BAG OF SOLUMEDROL ON DAY 2.

    Description of Event or Problem · 1

    BAXTER RECEIVED ONE USED INTERLINK BASIC SOLUTION SET FOR EVALUATION. THE SET WAS TESTED AT 8 PSI OF AIR, UNDERWATER. LEAKAGE WAS OBSERVED APPROXIMATELY 54" BELOW THE DRIP CHAMBER. THIS EVENT WAS DUE TO MARKS IN THE TUBING FROM THE ROLLER CLAMP ASSEMBLY. DURING INVESTIGATIONS OF VARIOUS COMPLAINT SAMPLES, IT WAS REVEALED THAT CUTS WERE OCCURRING IN THE SHUT OFF AREA OF THE ROLLER ASSEMBLY. A PROTRUSION IN THE SIDEWALL OF THE FRAME IS UTILIZED AS AN AID TO SHUT OFF FLUID FLOW. AT THIS SIDEWALL PROTRUSION, THE ROLLER PINCHES THE TUBING AND FLUID FLOW IS STOPPED. THIS PROTRUSION IN THE FRAME IS BELIEVED TO BE THE AREA WHERE THE TUBING WAS BEING CUT. MOST REPORTS OF LEAKAGE HAVE OCCURRED WHEN THE ROLLER ASSEMBLY IS IN THE OFF POSITION FOR A LONG PERIOD OF TIME. REPORTED INCIDENTS HAVE BEEN DETECTED IMMEDIATELY UPON THE REMOVAL OF THE ROLLER ASSEMBLY FROM THE OFF POSITION AND DURING PRIMING AND/OR FLUID ADMINISTRATION. NO ADVERSE PATIENT EVENTS HAVE BEEN REPORTED. IN JANUARY OF 2004 THE MATERIAL WAS CONVERTED FROM ABS LUSTRAN 348 TO ABS LUSTRAN 240. THE DEVICE REFERENCED IN THE REPORTS WAS MANUFACTURED IN SEPTEMBER OF 2003, PRIOR TO THE MATERIAL CHANGE. IMPROVEMENTS TO THE EXTRUSION PROCESS WERE ALSO IMPLEMENTED AT THAT TIME TO CORRECT THE ISSUE. THE USE OF A SPECIFIED PIN/BUSHING SIZE WAS ALSO ADDED AS A REQUIREMENT FOR ALL PRECISION TUBING, BOTH NON-DEHP AND STANDARD PVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER GRAVITY INFUSION TUBING FPA BAXTER HEALTHCARE CORPORATION 2C6425S S03129080R

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other