BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4042066 · Received August 27, 2014

    Report

    Report Number
    1416980-2014-28377
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM DECEMBER 2, 2013 TO DECEMBER 3, 2013. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION WITH APPROXIMATELY 95 ML OF FLUID IN ITS BLADDER. AFTER THE LUER CAP WAS REMOVED, VISUAL INSPECTION FOUND NO EVIDENCE OF FLOW AT THE DISTAL LUER, VERIFYING THE REPORTED CONDITION. FURTHER VISUAL INSPECTION IDENTIFIED CRYSTALLIZED DRUG BLOCKING THE FLUID PATH AT THE DISTAL END OF THE GLASS CAPILLARY, LOCATED INSIDE OF THE FLOW RESTRICTOR HOUSING. THE NO FLOW CONDITION OCCURRED DUE TO THE CRYSTALLIZED DRUG; HOWEVER, THE CAUSE OF THE CRYSTALLIZED DRUG WAS UNABLE TO BE DETERMINED. 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. 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 DID NOT DELIVER ANY OF ITS CONTENTS. THIS OCCURRED AFTER THE DEVICE WAS FILLED WITH 4700 MG OF FLUOROURACIL (NON-BAXTER PRODUCT) DILUTED WITH SODIUM CHLORIDE (TOTAL FILL VOLUME OF 94 ML) AND CONNECTED TO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519898 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N013

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL DILUTED WITH NACL