BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11412222 · Received March 4, 2021

    Report

    Report Number
    9617594-2021-00066
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP (LOT# 4981625) AND ONE USED BD ALARIS PUMP SET WERE RECEIVED AND VISUALLY INSPECTED. THE SPIROS WAS RETURNED SECURELY CONNECTED TO THE MALE LUER OF THE ALARIS SET. AS RECEIVED, THE SPIN FEATURE OF THE SPIROS WAS ACTIVATED AND SPINNING FREELY. NO VISIBLE DAMAGE OR ANOMALIES WERE IDENTIFIED. THE CONNECTED DEVICES RETURNED WERE PRIMED WITH WATER AT GRAVITY PRESSURE AND THEN LEAK TESTED. LEAKAGE OCCURRED FROM THE AREA OF THE SPIROS O-RING WHILE THE SPIROS WAS UNACTIVATED. THE REPORTED COMPLAINT OF LEAKAGE FROM THE SPIROS CAN BE CONFIRMED. THE SPIROS WAS DISASSEMBLED AND THE O-RING WAS FOUND TO BE TORN. THE PROBABLE CAUSE OF THE O-RING DAMAGE AND SUBSEQUENT LEAKAGE IS DUE TO AN ERROR DURING AUTOMATED ASSEMBLY. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT 11:00 AM AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED THE LEAK OF AN UNSPECIFIED CHEMOTHERAPY FROM THE BACK SIDE OF THE DEVICE. THE DEVICE WAS IN USE FOR 5 MINUTES AND SOMEONE STATED THEY SAW A DRIP. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT, NO HARM REPORTED, AND NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306698 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4981625 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1