BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SPIKE W/CLAVE

    MDR report key: 5758831 · Received June 29, 2016

    Report

    Report Number
    2025816-2016-00057
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 29, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3122951 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN OCTOBER 2015 CITING NO ANOMALIES. VISUAL RECEIVING INSPECTION: 06/10/2016 - RECEIVED ONE USED CH3493, BAG SPIKE W/CLAVE, ADDITIVE PORT AND CLAVE, LOT# 3122951. ONE USED PORT ADAPTER MAKE/MODEL UNKNOWN. THE SPIKE WAS NOT RETURNED WITH THE DEVICE. FUNCTIONAL TESTING: A USED CH3493 BAG SPIKE W/CLAVE, ADDITIVE PORT AND CLAVE WAS RETURNED FOR INVESTIGATION. THE SPIKE WAS BROKEN AT THE BASE. THE BREAK WAS TYPICAL OF A BEND BREAK. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF A BROKEN SPIKE ON THE CH3493 WAS CONFIRMED. THE SPIKE WAS BROKEN AT THE BASE. THE BREAK WAS TYPICAL OF A BEND BREAK BY THE USER OR PATIENT.

    Description of Event or Problem · 1

    COMPLAINT REGARDING ONE CH3493, BAG SPIKE W/CLAVE, ADDITIVE PORT AND CLAVE, LOT# 3122951 (MFD. 10-2016). REPORT STATES, "500ML CHEMO INFUSION WAS BEING RUN THROUGH CH3493. TOWARDS THE END OF THE INFUSION, THE SPIKE BROKE OFF. THE STAFF INVOLVED (NURSING AND PHARMACY) HAS BEEN INTERVIEWED AND NO ONE RECALLED DROPPING THE INFUSION OR APPLYING EXTRAORDINARY FORCE TO THE SPIKE." UNPROTECTED CHEMO EXPOSURE REPORTED AND THE END OF THERAPY. THERE WAS NO SERIOUS ADVERSE PATIENT/CLINICIAN CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412941 BAG SPIKE W/CLAVE BAG SPIKE W/CLAVE FPA ICU MEDICAL, INC. CH3493 3122951

    Patients

    Seq Age Sex Outcome Treatment
    1