BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOCLAVE

    MDR report key: 6712665 · Received July 13, 2017

    Report

    Report Number
    2025816-2017-00179
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 8, 2017
    Report Date
    July 13, 2017
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    UDI-DI
    00840619023713
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED LOT 3002746 SHOWS 1,800 UNITS WERE MANUFACTURED AND RELEASED WITH NO EXCEPTION DOCUMENTS CITED. VISUAL: PARTICULATES WERE OBSERVED IN THE LUMEN. FUNCTIONAL: PARTICLES OF DRY SPIKE ADAPTER DIAPHRAGM SHED WERE FOUND IN THE DRIP CHAMBER. PARTICLES OF DRY SPIKE ADAPTER DIAPHRAGM SHED WERE FOUND IN THE IV LINE. SUMMARY ANALYSIS: THE COMPLAINT OF MATERIAL BEING SHED INTO THE FLUID PATH WAS CONFIRMED. THE ISSUE APPEARS TO BE RELATED TO A USAGE TECHNIQUE THAT PROMOTES DRY SPIKE DIAPHRAGM SHEDDING DURING USE.

    Additional Manufacturer Narrative · 1

    REPORTED LOT 3002746 SHOWS (B)(4) UNITS WERE MANUFACTURED AND RELEASED WITH NO EXCEPTION DOCUMENTS CITED.

    Description of Event or Problem · 1

    POSSIBLE CH-12 "DRY SPIKE" PRODUCT FAILURE. THE DRY SPIKE APPEARS TO HAVE SHED PLASTIC FROM THE SPIKE INTO THE LINE. THE PLASTIC DID NOT REACH THE PATIENT. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    POSSIBLE CH-12 "DRY SPIKE" PRODUCT FAILURE. THE DRY SPIKE APPEARS TO HAVE SHED PLASTIC FROM THE SPIKE INTO THE LINE. THE PLASTIC DID NOT REACH THE PATIENT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491925 CHEMOCLAVE ADMIN SET FPA ICU MEDICAL CH-12 3002746 00840619023713

    Patients

    Seq Age Sex Outcome Treatment
    1