BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3910946 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21369
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED FEBRUARY 8, 2014 ¿ FEBRUARY 10, 2014. EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED A WHITE THREAD-LIKE PARTICLE 4.5 MM IN LENGTH HANGING FROM THE STRESS-MEMBER FILTER. THE PARTICLE WAS IDENTIFIED TO BE A POLYESTER MATERIAL VIA FOURIER TRANSFORM INFRARED (FT-IR) SPECTROPHOTOMETER SCANNING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE PARTICULATE MATTER WAS DUE TO THE STORAGE AND HANDLING OF THE STRESS MEMBER SUBASSEMBLIES. THERE IS A CAPA OPEN TO FURTHER INVESTIGATE THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN A LARGE VOLUME INFUSOR. THIS WAS NOTED AFTER FILLING WITH FLUOROURACIL. THE REPORTER DESCRIBED THE PARTICULATE MATTER AS A LOOSE FIBER THAT WAS ¿ATTACHED TO THE FILTER ON THE STRESS MEMBER.¿ THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387422 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B027

    Patients

    Seq Age Sex Outcome Treatment
    1