BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4122686 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33425
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS LOT WAS MANUFACTURED FROM APRIL 28, 2014 TO APRIL 29, 2014. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED THAT THERE WAS NO FLOW AT THE DISTAL LUER AFTER ITS CAP WAS REMOVED. THE REPORTED CONDITION WAS VERIFIED. A MICROSCOPIC INSPECTION IDENTIFIED THAT THERE WAS CRYSTALLIZED DRUG BLOCKING THE FLUID PATH INSIDE THE LUMEN OF THE GLASS CAPILLARY (LOCATED INSIDE OF THE FLOW RESTRICTOR HOUSING). THE NO FLOW OCCURRED DUE TO THE CRYSTALLIZED DRUG; HOWEVER, THE CAUSE OF THE CRYSTALLIZED DRUG IS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR EXPERIENCED A NO FLOW. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602068 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14D055

    Patients

    Seq Age Sex Outcome Treatment
    1