BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3903749 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20983
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM JANUARY 28, 2014 TO JANUARY 29, 2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITH 77 ML OF FLUID IN ITS BLADDER. VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS THEN PERFORMED, THOUGH THE EXACT CONDITIONS OF THE REPORTED EVENT COULD NOT BE REPLICATED AS THEY WERE NOT PROVIDED. THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR UNDERINFUSED. THIS OCCURRED DURING INFUSION OF 6G OF CEFEPIME IN NORMAL SALINE. THE DEVICE WAS FILLED WITH 250 ML OF SOLUTION AND WAS EXPECTED TO INFUSE FOR 24 HOURS THE REPORTER STATED THAT 33% OF THE FILL VOLUME REMAINED AT THE END OF THE INFUSION. 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
    380499 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A059

    Patients

    Seq Age Sex Outcome Treatment
    1 6G OF CEFEPIME| NORMAL SALINE