BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3230524 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18712
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION A RUPTURED BLADDER IN A NON-FOOTING POSITION WAS IDENTIFIED. THE BLADDER WAS MICROSCOPICALLY EXAMINED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. MICROSCOPIC INSPECTION OF THE RETURNED SAMPLE IDENTIFIED MARKINGS ON THE EXTERIOR SURFACE OF THE BLADDER NEAR THE RUPTURE LINE, WHICH IS AN INDICATION OF EXTERNAL DAMAGE. THE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF AN INFUSOR FILLED WITH AN ONCOLOGY DRUG HAD BURST, WHILE BEING DELIVERED/WALKED OVER TO THE PATIENT FOR USE. MOST OF THE SOLUTION REMAINED INSIDE THE HOUSING; HOWEVER, THERE WAS SOME LEAKAGE. THIS OCCURRED BEFORE USE; THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329551 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12M057

    Patients

    Seq Age Sex Outcome Treatment
    1