BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3120246 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12629
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF A USED SAMPLE REVEALED A RUPTURED BLADDER IN A NON-FOOTING POSITION. THE BLADDER WAS MICROSCOPICALLY INSPECTED AND FOUND AN ABRASION ON THE INTERIOR SURFACE OF THE BLADDER. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME (B)(6) INFUSOR?S BLADDER RUPTURED DURING FILLING. THIS OCCURRED AFTER THE SALINE WAS INJECTED, WHILE THE DEVICE WAS BEING FILLED MANUALLY WITH A NON-BAXTER DRUG, VIA A SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223017 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12H024

    Patients

    Seq Age Sex Outcome Treatment
    1