BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3972974 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25011
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM APRIL 16, 2014 TO APRIL 18, 2014. THE DEVICE WAS DISCARDED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. 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 FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INFUSOR LEAKED. THIS OCCURRED AFTER THE DEVICE WAS FILLED WITH FLUOROURACIL AND BEFORE PATIENT CONNECTION. THE LEAK WAS NOTICED AS THE USER WAS PLACING THE DEVICE IN A SEPTOBOX CONTAINER, WHICH ALREADY CONTAINED A LUER LOCK SYRINGE WITH A BOLUS OF 500 MG FLUOROURACIL. THE REPORTER STATED THAT APPROXIMATELY 6 ML OF SOLUTION LEAKED FROM WHAT SEEMED TO BE THE END OF THE ADMINISTRATION TUBING, NEAR THE CAP. THE SOLUTION CAME IN CONTACT WITH THE USER¿S HAND; HOWEVER, 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
    451451 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14D030

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR