BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3222194 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18062
    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). 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 AND LEAK TESTING DID NOT REVEAL ANY EVIDENCE OF LEAKING; THE REPORTED PROBLEM WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF LEAKAGE. A LEAK TEST SHOWED NO SIGNS OF LEAKAGE ON ANY PART OF THE DEVICE. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322566 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N058

    Patients

    Seq Age Sex Outcome Treatment
    1