BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6072278 · Received November 2, 2016

    Report

    Report Number
    2025816-2016-00212
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 15, 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# 324410 SHOWED (B)(4) WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN APRIL 2016, THERE WERE NO EXCEPTION DOCUMENTS. VISUAL RECEIPT: ON (B)(4) 2016 RECEIVED ONE, CH2000S, SPINNING SPIROS, REPORTED LOT# 324410. NO MATING DEVICES WERE RETURNED. THE SPIN FEATURE HAD BEEN ACTIVATED. FUNCTIONAL TESTING: A SINGLE USED CH2000S SPINNING SPIROS WAS RETURNED FOR INVESTIGATION OF DISCONNECT FROM A SYRINGE. NO SYRINGE WAS RETURNED. THE CH2000S SPINNING SPIROS WAS RETURNED WITH THE SPIN FEATURE ACTIVATED. THE SHEAR TAB WAS VISIBLE BUT NOT IN THE SPIN PATH OF THE GATE WELL. THE RESIDUAL DISCONNECT TORQUE WAS MEASURED AT 0.06IN-LBS. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF CH2000S SPINNING SPIROS PREMATURE DISCONNECT FROM A SYRINGE COULD NOT BE CONFIRMED. NO MATING SYRINGE WAS RETURNED TO EVALUATE WITH THE CH2000S SPINNING SPIROS. AS DESIGNED, THE CH2000S SPINNING SPIROS WAS FREE SPINNING WHEN RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE, CH2000S, SPINNING SPIROS, LOT# 2844003 (MFD. APRIL 2014). REPORT STATES, SPIROS WAS DISCONNECTED FROM A SYRINGE AFTER SPIROS WAS TURNED. THERE WAS NO CLICK WHEN SPIROS CONNECTED TO A SYRINGE. PROPER PPE WAS UTILIZED. NO ADVERSE CLINICIAN OR PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723573 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. CH2000S 3244010

    Patients

    Seq Age Sex Outcome Treatment
    1