BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3900456 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20671
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 21, 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). THERAPY DATES: MAR 19, 2013 TO MAR 21, 2013. THIS LOT WAS MANUFACTURED BETWEEN SEPTEMBER 5, 2013 AND SEPTEMBER 6, 2013. EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING 6ML OF FLUID IN THE BLADDER. VISUAL INSPECTION ON THE UNIT SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE RATE WAS FOUND TO BE WITHIN SPECIFICATION. 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.

    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 17 OF 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377688 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