BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3900441 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20667
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 9, 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). LOT NUMBER 13J010 WAS MANUFACTURED BETWEEN SEPTEMBER 5, 2013 AND SEPTEMBER 6, 2013. UPON FOLLOW UP WITH THE CUSTOMER IT WAS FOUND THAT THE INFUSION WAS EXPECTED TO HAVE OCCURRED OVER 48 HOURS, HOWEVER, IT WAS COMPLETED IN APPROXIMATELY 31 HOURS. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION ON THE UNIT SHOWED NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON THE UNIT. THE FLOW RATES WERE FOUND TO BE WITHIN THE SPECIFICATION RANGE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT OCCURRENCE DATE IS UNKNOWN; HOWEVER, THIS WAS REPORTED TO HAVE OCCURRED (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.

    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 16 OF 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377683 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