BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3802311 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14903
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K884505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS OCCURRED DURING FILLING WITH THREE NON-BAXTER DRUGS AND NORMAL SALINE. THE INTENDED FILL VOLUME WAS 100 ML. THE LOT WAS MANUFACTURED FROM NOVEMBER 22, 2011 TO NOVEMBER 23, 2011. EVALUATION SUMMARY: VISUAL INSPECTION FOUND NO EVIDENCE OF A RUPTURED RESERVOIR. A FUNCTIONAL LEAK TEST WAS THEN PERFORMED BY REFILLING THE RESERVOIR WITH COLORED WATER AND OBSERVING FOR LEAKAGE; AGAIN, NO EVIDENCE OF A RUPTURED RESERVOIR WAS IDENTIFIED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A BASAL/BOLUS INFUSOR RUPTURED. THIS OCCURRED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280459 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11M054

    Patients

    Seq Age Sex Outcome Treatment
    1