BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6303592 · Received February 6, 2017

    Report

    Report Number
    2025816-2017-00036
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 18, 2017
    Report Date
    February 6, 2017
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO YEAR REVIEW SHOWED ONE OTHER COMPLAINT FOR THIS FACILITY.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 20130-01, SPINNING SPIROS, LOT# IS UNKNOWN. REPORT STATES: SPIROS DISCONNECTED FROM CAREFUSION TUBING. UNPROTECTED CHEMO EXPOSURE REPORTED. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87462 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. 20130-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1