BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4241333 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39723
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED BETWEEN JULY 22, 2014- JULY 23, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE RESERVOIR OF A LARGE VOLUME INFUSOR. THIS WAS NOTED AFTER FILLING. THE REPORTER STATED THAT A FILTER WAS USED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 9 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723615 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14G045

    Patients

    Seq Age Sex Outcome Treatment
    1