BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6072225 · Received November 2, 2016

    Report

    Report Number
    2025816-2016-00209
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 6, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: LOT# 2844003 SHOWED 11,000 UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN APRIL 2016, THERE WERE NO EXCEPTION DOCUMENTS. VISUAL RECEIPT: ON 10/11/2016 RECEIVED THE FOLLOWING: ONE USED CH2000S, SPINNING SPIROS, REPORTED LOT# 2844003. TWO USED 081-CH-10 CHEMOCLAVE BAG SPIKE LOT# UNKNOWN. ONE USED IV CONTAINER 50ML. ONE USED ADMIN SET. ONE 081-CH-10 WAS SPIKED INTO THE 50ML CONTAINER. THE SPIROS WAS CONFIRMED TO BE DAMAGED, THE FEMALE LUER WAS SEPARATED FROM THE SPIROS HOUSING. FUNCTIONAL TESTING: THE CH2000S SPINNING SPIROS WAS BROKEN AT THE ULTRASONIC WELD. THE WELD WAS MICROSCOPICALLY EXAMINED. THE ENERGY DIRECTORS WERE NOT WELL CONSUMED SUGGESTING AN INADEQUATE ULTRASONIC WELD. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF CH2000S SPINNING SPIROS WELD BOND BREAKAGE WAS CONFIRMED. THE BREAKAGE WAS DUE TO AN INADEQUATE ULTRASONIC WELD. ICU MEDICAL HAS MADE WELD IMPROVEMENTS THAT HAVE STRENGTHENED THE BOND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE, CH2000S, SPINNING SPIROS, LOT# 2844003 (MFD. APRIL 2014). REPORT STATES, SPIROS WHICH WAS CONNECTED WITH 081-CH-10 AND AN INFUSION SET WAS SEPARATED HALF AN HOUR AFTER CONNECTION AND ENDOXAN LEAKED. UNPROTECTED CHEMO EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723962 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. CH2000S 2844003

    Patients

    Seq Age Sex Outcome Treatment
    1