BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4102993 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32374
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN MAY 23, 2014 AND MAY 24, 2014. EVALUATION SUMMARY: BAXTER RECEIVED THE UNIT FOR EVALUATION. VISUAL INSPECTION NOTED FLUID INSIDE THE PACKAGE THAT CONTAINED THE UNIT. WHEN THE UNIT WAS REMOVED FROM THE PACKAGE, THE CAUSE OF FLUID INSIDE THE PACKAGE WAS VISUALLY IDENTIFIED TO BE UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS PERFORMED. AFTER FILLING THE UNIT, THE BLUE WINGED LUER CAP WAS HAND TIGHTENED AND THEN THE UNIT WAS BEING MONITORED UNTIL THE NEXT DAY. THE NEXT DAY, NO SIGNS OF LEAK WERE OBSERVED AT THE BLUE WINGED LUER CAP. THE UNIT MET PRODUCT SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED INTO ITS OVER POUCH. THIS WAS FOUND BEFORE USE. THE DEVICE WAS FILLED WITH 4000 MG OF FLUOROURACIL TO A TOTAL OF 230 ML OF SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582220 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E050

    Patients

    Seq Age Sex Outcome Treatment
    1