BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 5191732 · Received October 30, 2015

    Report

    Report Number
    1416980-2015-40520
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Report Date
    November 10, 2015
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (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). THIS LOT WAS MANUFACTURED FROM JANUARY 30, 2015 TO JANUARY 31, 2015. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND FLOW RATE TESTING WERE PERFORMED. THE DEVICE WAS FOUND TO FLOW WITHIN SPECIFICATION. NO MALFUNCTIONS OR ABNORMALITIES WERE IDENTIFIED DURING THE EVALUATION OF THE DEVICE. 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 A SMALL VOLUME FOLFUSOR UNDERINFUSED WHILE DELIVERING ANTIBIOTICS. THERE WAS NO REPORT OF 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
    720813 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 15A055

    Patients

    Seq Age Sex Outcome Treatment
    1