BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4141837 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34524
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JUNE 26, 2014 TO JUNE 27, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED A SINGLE BLACK IRREGULARLY SHAPED PARTICLE, APPROXIMATELY 0.02 MM IN SIZE, EMBEDDED IN A STRESS-MEMBER PLUG MATERIAL. THE CAUSE OF THE PRESENCE OF THE PARTICULATE MATTER COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SMALL BLACK PARTICLE ¿NEAR THE END OF THE CENTRAL STEM INSIDE THE BALLOON¿ OF A LARGE VOLUME INFUSOR. THIS WAS NOTED DURING FILLING OF THE DEVICE WITH 5-FLUOROURACIL AND SODIUM CHLORIDE 0.9%. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621472 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F054

    Patients

    Seq Age Sex Outcome Treatment
    1