BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE BAG SPIKE W/ADDITIVE PORT

    MDR report key: 3973120 · Received June 5, 2014

    Report

    Report Number
    2025816-2014-00050
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 5, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED CH-13 DEVICES/SPIKE COMPONENTS. THE RESULTS RECORDED NO VISUAL DEFECTS, DIMENSIONAL ANOMALIES AND OR OUT OF SPEC CONDITIONS. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED CH-13 CLAVE BAG SPIKE AND MATING SET-UP DEVICES WAS PERFORMED. SET-UPS/CONNECTIONS WERE EACH MEASURED VIA USE OF DIGITAL FORCE GAUGES. THE VALUES RECORDED ALL CH-13 COMPONENTS/MATED DEVICES REMAINED ATTACHED PER ACCEPTABLE SPECIFICATIONS/REMOVAL FORCES. THERE WERE NO FUNCTIONAL AND OR PERFORMANCE ISSUES REPLICATED IN THE LABORATORY SETTING. THE REPORTED DISCONNECTS AND LEAKAGE ISSUES COULD ONLY BE REPLICATED WHEN THE MATING COMPONENTS WERE NOT FULLY SEATED/MATED. THE ENGINEERING REPORT DID IDENTIFY POTENTIAL DESIGN/GEOMETRY VARIATIONS IN THE 500ML SALINE BAG MATING DEVICE PORT COMPONENTS WHICH MAY HAVE CONTRIBUTED TO REMOVAL FORCE VARIATIONS BETWEEN THE TWO MANUFACTURERS PRODUCTS. THE CH-13 COMPLAINT INVESTIGATION REPORT, RELEVANT PHOTOGRAPHS WERE PROVIDED TO THE REPORTING FACILITY FOR THEIR REVIEW, UNDERSTANDING AND RECORDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING DISCONNECTS/LEAKAGES WITH SET-UPS INVOLVING USE OF CH-13 CLAVE BAG SPIKE W/ADDITIVE PORT DEVICES AND CAREFUSION SMARTSITE INFUSION SETS, BAXTER AND HOSPIRA 500ML SALINE BAGS. THE INFO FOR THE FIRST EVENT REPORTS ". THE BAG SPIKE/TUBING CAME OUT WHILE HANGING - LARGE CHEMO SPILL. CHEMO SPLASHED ON NURSE. NURSE WAS OUTFITTED WITH PPE BUT THE CHEMO SPILL/SPLASH STILL RESULTED IN UNPROTECTED CHEMO (SKIN) EXPOSURE. PT WAS NOT ADVERSELY AFFECTED." TWO ADD'L INCIDENTS WERE REPORTED WHERE "THE NURSE WENT TO PICK UP THE PREPARED SET-UPS/BAGS FROM THE PHARMACY AND THE PHARMACIST FOUND THE CH-13 CAME OUT. IV BAGS LEAKING IN THE DELIVERY BAGS/STORAGE BINS." THE CHEMO SPILLS/LEAKAGES WERE CLEANED/CONTAINED PER HOSP PROTOCOL. THE IDENTIFIED DEVICES WERE DISCARDED. DEVICE RETURN: THREE (3) PKGD. CH-13 CLAVE BAG SPIKE DEVICES, LOT # 2802862; FOUR (4) PKGD. CAREFUSION SMARTSITE INFUSION SETS, TWO (2) PKGD BAXTER 500ML SALINE BAGS AND TWO (2) PKGD 500ML SALINE BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328710 CLAVE BAG SPIKE W/ADDITIVE PORT CLAVE BAG SPIKE W/ADDITIVE PORT FMF ICU MEDICAL, INC. CH-13 2802862

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CAREFUSION SMARTSITE INFUSION SETS| BAXTER AND HOSPIRA 500ML SALINE BAGS