BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4211966 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37952
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JUNE 26, 2014 TO JUNE 27, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE COILED CAP WAS OBSERVED TO BE SEPARATED FROM THE HOUSING OF THE DEVICE. THIS WAS DUE TO THE HOUSING BEING MALFORMED. 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 MALFORMED HOUSING IS UNKNOWN. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COILED CAP OF A LARGE VOLUME INFUSOR SEPARATED FROM THE HOUSING. THIS EVENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693856 INFUSOR PUMP, INFUSION MEB BAXTER HEALTHCARE - IRVINE 14F054

    Patients

    Seq Age Sex Outcome Treatment
    1