BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 8866803 · Received August 6, 2019

    Report

    Report Number
    1416980-2019-04313
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 11, 2019
    Report Date
    September 10, 2019
    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 · 0

    CATALOGUE # 2C1009KP PREVIOUSLY SUBMITTED AS ASKU. LOT # 19C022 PREVIOUSLY SUBMITTED AS ASKU. PMA/510K # K071222 PREVIOUSLY SUBMITTED AS NI. THE DEVICE WAS MANUFACTURED BETWEEN MARCH 06, 2019 - MARCH 08, 2019. THE DEVICE WAS RECEIVED WITH NO FLUID IN THE BLADDER. A VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATED TEST WAS PERFORMED. THE FLOW RATES WERE FOUND TO BE WITHIN THE PRODUCT SPECIFICATION RANGE, THEREFORE, THE PRODUCT MET SPECIFICATION. THE REPORTED CONDITION WAS NOT VERIFIED. 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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED LARGE VOLUME DEVICE COMPLETED INFUSION WITHIN 36 HOURS; INFUSION TIME WAS SPECIFIED AT 48 HOURS. THIS WAS IDENTIFIED AFTER PATIENT USE. THE DEVICE CONTAINED FLUOROURACIL. 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
    658867 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 19C022

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL