BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3901433 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20786
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    January 13, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT OCCURRENCE DATE IS UNKNOWN; HOWEVER, THIS WAS REPORTED TO HAVE OCCURRED BETWEEN (B)(6) 2014. 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). INFUSION WITH THE DEVICE WAS STARTED AT 8 PM ON (B)(6) 2014. INFUSION FINISHED AT 9 AM ON (B)(6) 2014 INSTEAD OF THE EXPECTED 8 PM ON (B)(6) 2014. THE DEVICE WAS MANUFACTURED BETWEEN SEPTEMBER 5, 2013 AND SEPTEMBER 6, 2013. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 8 ML OF FLUID WITHIN ITS BLADDER. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. A FUNCTIONAL FLOW RATE TEST RESULTED IN A CALCULATED FLOW RATE OF 2.37 ML/HR AND A NORMALIZED FLOW RATE OF 2.43 ML/HR, BOTH OF WHICH ARE WITHIN THE SPECIFICATION RANGE OF 2.25 ¿ 2.75 ML/HR. THE REPORTED PROBLEM WAS NOT VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. 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 OVERINFUSED. THE REPORTER STATED THAT THE EXPECTED THERAPY TIME WAS 48 HOURS; HOWEVER, THE DEVICE COMPLETED INFUSION IN LESS THAN 48 HOURS. THE DEVICE HAD BEEN FILLED WITH AN UNSPECIFIED DRUG IN 120ML OF 0.9% SODIUM CHLORIDE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381008 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13J010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED DRUG IN 120ML OF 0.9% SODIUM CHLORIDE