BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3900410 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20663
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 22, 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 02 JAN 2014 AND 03 MAR 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). THE ACTUAL INFUSION TIME WAS 42 HOURS AND 15 MINUTES. THE LOT WAS MANUFACTURED FROM SEPTEMBER 5, 2013 TO SEPTEMBER 6, 2013. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION WITH NO FLUID IN ITS BLADDER. VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED, AND THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. 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 15 OF 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377015 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