BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS

    MDR report key: 5955726 · Received September 16, 2016

    Report

    Report Number
    2025816-2016-00144
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 16, 2016
    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

    LOT# REVIEW: A REVIEW OF SUSPECT LOT# 3269216 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN JUNE 2016 CITING NO ANOMALIES. RECEIVING REVIEW: 8/31/2016 - RECEIVED THE FOLLOWING DEVICES: ONE CH2000S-PC, SPINNING SPIROS WITH PURPLE CAP REPORTED LOT# 3269216. ONE USED EXACTMIX IV BAG 1000ML ONE USED CHEMOCLAVE BAG SPIKE WITH ADDITIVE PORT LOT# UNKNOWN ONE USED CAREFUSION PUMPSET CONNECTION SETUP: EXACTAMIX IV BAG --> CHEMOCLAVE BAG SPIKE WITH ADDITIVE PORT --> CAREFUSION PUMPSET. THE SPIROS WAS NOT ATTACHED TO THE SETUP. FUNCTIONAL TESTING: ONE USED CH2000S-PC SPINNING SPIROS WAS RETURNED FOR INVESTIGATION. THE CH2000S-PC SPINNING SPIROS WAS NOT CONNECTED TO THE CAREFUSION PUMP SET. THE CAREFUSION PUMP SET HAD A BLUE "C-CLIP" ON THE MALE SPIN LUER. THE RESIDUAL SPIN TORQUE WAS MEASURED ON THE CH2000S-PC SPINNING SPIROS AT 0.09IN-LBS. THE BLUE "C-CLIP" WAS REMOVED FROM THE CAREFUSION MALE SPIN LUER. THE CH2000S-PC SPINNING SPIROS WAS CONNECTED TO THE CAREFUSION MALE SPIN LUER AT A CONNECTION TORQUE OF 1.3IN-LBS. THE BLUE "C-CLIP" WAS REINSTALLED ONTO THE CAREFUSION MALE SPIN LUER. ATTEMPTS WERE MADE TO TRY TO DISCONNECT THE CH2000S-PC SPINNING SPIROS FROM THE CAREFUSION MALE SPIN LUER. THE CH2000S-PC SPINNING SPIROS WAS UNABLE TO BE DISCONNECTED. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF PREMATURE DISCONNECT OF THE CH2000S-PC SPINNING SPIROS FROM THE CAREFUSION MALE SPIN LUER WAS UNABLE TO BE REPLICATED. THE RESIDUAL SPIN TORQUE OF THE CH2000S-PC SPINNING SPIROS WAS LOW AND DID NOT RESULT IN A PREMATURE DISCONNECT FROM THE CAREFUSION MALE SPIN LUER.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CH2000S-PC, SPINNING SPIROS WITH PURPLE CAP. REPORT STATES, SPIROS DISCONNECTED FROM CAREFUSION TUBING WHEN LEAKING. UNPROTECTED CHEMO EXPOSURE REPORTED DUE TO LEAK BUT NO PHYSICAL CONTACT WITH THE PATIENT OR CLINICIANS. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608887 SPINNING SPIROS SPINNING SPIROS FPA ICU MEDICAL, INC. CH2000S-PC 3269216

    Patients

    Seq Age Sex Outcome Treatment
    1