BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3251735 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19827
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. MICROSCOPIC EXAMINATION OF THE BLADDER REVEALED MARKING ON THE INTERIOR SURFACE OF THE BLADDER NEAR THE RUPTURE LINE. THIS IS AN INDICATION OF INTERNAL DAMAGE. THE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION A RUPTURED BLADDER IN A FOOTING POSITION WAS IDENTIFIED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LARGE VOLUME INTERMATE'S BLADDER RUPTURED AT THE END OF THE INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351820 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11K034

    Patients

    Seq Age Sex Outcome Treatment
    1