BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4100284 · Received September 18, 2014

    Report

    Report Number
    1416980-2014-32110
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM FEBRUARY 6, 2014 TO FEBRUARY 8, 2014. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY ABNORMALITIES THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TESTING WAS PERFORMED, AND THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. THE REPORTED CONDITION WAS UNABLE TO BE 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

    (B)(4). THIS OCCURRED FROM (B)(6) 2014. (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDER INFUSED WITH A PATIENT AT THEIR HOME. THE DEVICE WAS FILLED WITH FLUOROURACIL AND SALINE SOLUTION TOTALING 210 ML. THE DEVICE WAS PRIMED TO CONFIRM FLOW. THE EXPECTED INFUSION TIME WAS 46 HOURS. AFTER 46 HOURS THE DEVICE HAD ONLY DELIVERED APPROXIMATELY 30 ML OF FLUID. THE PHARMACIST FOUND NO OCCLUSIONS IN THE ADMINISTRATION PORT OR LINE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580498 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B004

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE SOLUTION| FLUOROURACIL