BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3222175 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18061
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED THAT THERE WAS A TINY CHUNK OF WHITE CRYSTALLIZED DRUG LOCATED AT THE CONNECTION OF THE RED LUER CAP AND THE WHITE LUER. IT WAS ALSO NOTED THAT THE DEVICE WAS RECEIVED WITH A NON-BAXTER RED LUER CAP. THE CAP WAS NOT CLOSED ALL THE WAY. THE LEAK WAS DUE TO AN INSECURE FIT OF THE NON-BAXTER CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR LEAKED AFTER FILLING. THE DEVICE WAS FILLED WITH A SOLUTION OF FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322562 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N058

    Patients

    Seq Age Sex Outcome Treatment
    1