BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3973561 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25099
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT OCCURRENCE DATE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT IT OCCURRED DURING THE WEEK OF (B)(6) 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM MAY 28, 2014 TO MAY 29, 2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION NOTED FLUID INSIDE THE PACKAGE THAT CONTAINED THE UNIT, WHICH INDICATED LEAKAGE HAD OCCURRED. A FUNCTIONAL LEAK TEST WAS THEN PERFORMED IN WHICH THE DEVICE WAS FILLED WITH COLORED WATER, THE BLUE WINGED LUER CAP WAS TIGHTENED BY HAND, AND THE SAMPLE WAS OBSERVED FOR LEAKAGE UNTIL THE FOLLOWING DAY. AFTER THE NEXT DAY, NO SIGNS OF LEAKAGE WERE OBSERVED AT THE BLUE WINGED LUER CAP. NO DEFECTS WITH THE DEVICE WERE IDENTIFIED DURING EVALUATION. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE AN UNTIGHTENED BLUE WINGED LUER CAP. 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 LEAKED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451571 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E058

    Patients

    Seq Age Sex Outcome Treatment
    1