BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 6013930 · Received October 10, 2016

    Report

    Report Number
    1416980-2016-16094
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION ON THE RETURNED UNIT VIA THE NAKED EYE SHOWED A DENT ON A SEGMENT OF THE TUBING. THERE WAS CONTINUOUS FLOW AFTER THE DISTAL LUER WAS REMOVED. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED WITH THE RATE BEING WITHIN SPECIFICATION. THE REPORTED CONDITION WAS NOT VERIFIED. 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 HAD CRACKED TUBING. THIS OCCURRED DURING FILLING. THE FOLFUSOR WAS BEING FILLED WITH SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665405 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 16B006

    Patients

    Seq Age Sex Outcome Treatment
    1