BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 5091026 · Received September 21, 2015

    Report

    Report Number
    1416980-2015-36644
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 7, 2015
    Report Date
    October 6, 2015
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM MARCH 1, 2015- MARCH 2, 2015. ONE UNIT WAS RECEIVED AT THE PLANT FOR ANALYSIS. VISUAL INSPECTION NOTED A RUPTURED BLADDER. THE RUPTURED BLADDER WAS MICROSCOPICALLY EXAMINED AND AS A RESULT, A MARKING LOCATED ON THE INTERIOR SURFACE OF THE BLADDER WAS OBSERVED NEAR THE RUPTURE LINE. THE CAUSE COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 THE BLADDER OF A LARGE VOLUME INFUSOR RUPTURED NEAR THE END OF INFUSION. THE DEVICE HAD BEEN FILLED MANUALLY USING A SYRINGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622202 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 15C002

    Patients

    Seq Age Sex Outcome Treatment
    1