BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS

    MDR report key: 9673100 · Received February 5, 2020

    Report

    Report Number
    9617594-2020-00037
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619042769
    PMA / PMN Number
    K070532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A USED CH2000SC-10 SPINNING SPIROS WAS RETURNED CONNECTED AT THE DISTAL END OF AN ALARIS PUMP SET TO A MALE SPIN LUER. THE SPIN FEATURE WAS ACTIVATED IN THE ROTATIONAL DIRECTION AS DESIGNED AND SPINNING FREELY WHEN RECEIVED FOR INVESTIGATION. WHEN EVALUATED THE SPIN COLLAR OF THE ALARIS MALE SPIN LUER WAS SECURELY ATTACHED TO THE FEMALE LUER OF THE CH2000SC-10 SPINNING SPIROS. THERE WAS NO DAMAGE TO THE USED CH2000SC-10 SPINNING SPIROS THAT WOULD HAVE RESULTED IN A PREMATURE DISCONNECT. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. A DEVICE HISTORY REVIEW FOR LOT# 4120021 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPIROS, CLOSED MALE LUER W/RED CAP THAT WHEN YOU ATTACH THE SPIROS TO THE END OF A PRIMARY TUBING OR NITRO TUBING THAT IT LOCKS BUT YOU CAN UNLOCK IT. THE CUSTOMER DID CONFIRM THAT IT DOES NOT LEAK; HOWEVER, THEY HAVE A NURSE WHO PULLED IT OFF BY ACCIDENT AND THE CHEMO WERE EVERYWHERE. THE CUSTOMER STATED ANYTIME A SPIROS IS REMOVED FROM THE TUBING, THERE IS A SMALL AMOUNT OF EXPOSURE. ADDITIONALLY, IN THE EVENT OF A HAZARDOUS SPILL, THE HAZARDOUS SPILL PROTOCOL IS ALWAYS FOLLOWED. THERE IS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, BUT THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132606 SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4120021 00840619042769

    Patients

    Seq Age Sex Outcome Treatment
    1