BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 6072229 · Received November 2, 2016

    Report

    Report Number
    2025816-2016-00210
    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# 3207397 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH 2016, THERE WERE NO EXCEPTION DOCUMENTS. VISUAL RECEIPT: 10/24/2016 - ON 10/11//2016 RECEIVED ONE USED CH2000S, SPINNING SPIROS, REPORTED LOT# 2844003. NO MATING DEVICES WERE RETURNED. THE SPIN FEATURE OF THE SPIROS HAD BEEN ACTIVATED. FUNCTINAL TESTING: A SINGLE USED CH2000S SPINNING SPIROS WAS RETURNED FOR INVESTIGATION OF PREMATURE DISCONNECT FROM A SYRINGE. NO MATING SYRINGE WAS RETURNED TO EVALUATE WITH THE CH2000S SPINNING SPIROS. THE SPIN FEATURE OF THE CH2000S SPINNING SPIROS WAS ACTIVATED WHEN RETURNED AND WAS SPINNING FREELY. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF CH2000S SPINNING SPIROS PREMATURE DISCONNECT FROM A LUER LOCK SYRINGE WAS UNABLE TO BE CONFIRMED. NO MATING DEVICE WAS RETURNED TO EVALUATE WITH THE CH2000S SPINNING SPIROS. THE SPIN FEATURE WAS ACTIVATED AND SPINNING FREELY WHEN RETURNED FOR INVESTIGATION. THE RESIDUAL DISCONNECT WAS VERY LOW AND WOULD NOT CONTRIBUTE TO PREMATURE DISCONNECT FROM A SYRINGE.

    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 (NIPRO 20ML). THE USER CONFIRMED THAT SPIROS WAS FIRMLY SECURED TO THE SYRINGE AND SPUN BEFORE USE. PROPER PPE WAS UTILIZED. NO ADVERSE CLINICIAN OR PATIENT CONSEQUENCES REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723431 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. CH2000S 3207397

    Patients

    Seq Age Sex Outcome Treatment
    1