BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6238973 · Received January 10, 2017

    Report

    Report Number
    2025816-2016-00294
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 14, 2016
    Report Date
    January 10, 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

    SUSPECT LOT REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR SUSPECT LOT# 67-326-Y1 (MFG. DATE 08/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED CITING NO EXCEPTION DOCUMENTS. A REVIEW OF THE MFG. LOT DATABASE FOR SUSPECT LOT# 61-522-SJ (MFG. DATE 04/2016) SHOWS (B)(4) UNITS WERE MFD., TESTED, INSPECTED, AND RELEASED CITED NO EXCEPTION DOCUMENTS. VISUAL RECEIPT ANALYSIS: 12/29/2016 - RECEIVED THE FOLLOWING: TWO USED 20130-01, SPINNING SPIROS CLOSED MALE LUER, RED CAP; REPORTED LOT# 66-747-SL ONE USED MICROCLAVE CONNECTOR LOT# UNKNOWN, ONE USED TUBING EXTENSION, ONE USED BD 30 ML SYRINGE. FUNCTIONAL TESTING: THE RESIDUAL TORQUE OF THE SPIN FEATURE OF THE STAND ALONE SPIROS WAS MEASURED AT 0.03 IN-LBS. FINAL ANALYSIS SUMMARY: THE REPORT OF 20130-01 DISCONNECT WAS UNABLE TO BE CONFIRMED. WHEN A LARGE SYRINGE IS CONNECTED TO A SPIROS ASSEMBLY THIS CREATES A LONG LEVER AND CARE NEEDS TO BE TAKEN TO SUPPORT THE SPIROS AND NOT APPLY BENDING FORCES DURING USE. FAILURE TO DO SO CAN RESULT IN PREMATURE DISCONNECT. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    COMPLAINT REC'D REGARDING ONE (1) 20130-01, SPINNING SPIROS CLOSED MALE LUER, RED CAP; LOT# UNKNOWN. THE REPORT STATES, SPINNING SPIROS COMING DISCONNECTED FROM THE SYRINGE DURING THE PATIENT INFUSION. RESULTING IN CHEMO SPILL EXPOSING THE CHILD, FAMILY AND NURSING STAFF. THERE WAS AN UNSPECIFIED AMOUNT OF CHEMO EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19046 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. 20130-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR