BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6072231 · Received November 2, 2016

    Report

    Report Number
    2025816-2016-00211
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 23, 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) 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, LOT# 2844003, ONE USED 100ML IV ADMIN CONTAINER, ONE USED ADMIN SET. THE SPIROS WAS NOT CONNECTED TO ANOTHER DEVICE. THE SPIN FEATURE OF THE SPIROS HAD BEEN ACTIVATED. FUNCTIONAL TESTING: A SINGLE USED CH2000S SPINNING SPIROS WAS RETURNED SEPARATE FROM A USED ADMINISTRATION SET. THE SPIN FEATURE WAS ACTIVATED AND SPINNING FREELY. THE CH2000S, SPINNING SPIROS WAS CONNECTED TO THE MALE LUER LOCK OF THE USED ADMINISTRATION SET AT A CONNECTION TORQUE OF 1.3IN-LBS. THE RESIDUAL DISCONNECT TORQUE WAS MEASURED AT 0.11IN-LBS. THE DISCONNECT TORQUE WAS MEASURED AT 1.01IN-LBS. FINAL ANALYSIS SUMMARY: THE CH2000S SPINNING SPIROS WAS RETURNED DISCONNECTED FROM THE RETURNED ADMINISTRATION SET. WHEN THE CH2000S SPINNING SPIROS WAS RECONNECTED TO THE RETURNED ADMINISTRATION SET THE SPIROS DID NOT SHOW ANY PROPENSITY TO DISCONNECT PREMATURELY.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE, CH2000S, SPINNING SPIROS, LOT# 2844003 (MFD. APRIL 2014). REPORT STATES, SPIROS WAS DISCONNECTED FROM AN INFUSION SET AFTER SPIROS WAS TURNED TO REVERSE. PROPER PPE WAS UTILIZED. NO ADVERSE CLINICIAN OR PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724721 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. CH2000S 3244010

    Patients

    Seq Age Sex Outcome Treatment
    1