BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3901458 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20781
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    March 1, 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 9 AM ON (B)(6) 2014. INFUSION FINISHED AT 10:15 PM ON (B)(6) 2014 INSTEAD OF THE EXPECTED 9 AM 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. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. A FUNCTIONAL FLOW RATE TEST RESULTED IN A CALCULATED FLOW RATE OF 2.57 ML/HR AND A NORMALIZED FLOW RATE OF 2.64 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 7 OF 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380663 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