BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS®, CLOSED MALE LUER

    MDR report key: 9309480 · Received November 12, 2019

    Report

    Report Number
    9617594-2019-00390
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619033903
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER, A PHOTOGRAPH WAS PROVIDED AND EVALUATED. THE PHOTO SHOWS ONE (1) CH2000S SPINNING SPIROS CONNECTED TO A BAXTER ELASTOMERIC PUMP AT THE FEMALE LUER END OF THE SPRIOS. NO CLEAR LEAKAGE FROM THE SPIROS IS VISIBLE IN THE PHOTOGRAPH. THE DHR FOR LOT 4090439 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MFR NARRATIVE: ONE (1) USED CH2000S, SPINNING SPIROS (LOT# 4090439) CONNECTED TO ONE (1) USED PARTIAL ELASTOMERIC INFUSION PUMP WITH A CLAMP AND ONE (1) USED CH2000S, SPINNING SPIROS (LOT# 4090439) CONNECTED TO ONE (1) USED CONNECTOR AND PARTIAL EXTENSION SET FROM AN UNKNOWN MANUFACTURER WERE RECEIVED AND VISUALLY INSPECTED ON 05-DEC-2019. AS RECEIVED, THE SPIN FEATURE ON BOTH SPIROS WAS ACTIVATED IN THE ROTATIONAL DIRECTION. NO DAMAGE OR ANOMALIES WERE IDENTIFIED ON THE CH2000S DEVICES. BOTH SPINNING SPIROS WERE DISCONNECTED FROM THE RETURNED MATING DEVICES AND HYDROSTATIC PRESSURE LEAK TESTED ACCORDING TO PRODUCT PERFORMANCE SPECIFICATIONS. NO LEAKAGE WAS IDENTIFIED. THE COMPLAINT COULD NOT BE CONFIRMED. THE REPORTED LEAKAGE COULD NOT BE REPLICATED HOWEVER, SUCH LEAKAGE CAN OCCUR DUE TO MISUSE OF THE SPIROS WHEN USED WITH ELASTOMERIC PUMPS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR INVESTIGATION, HOWEVER, IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPIROS DEVICE THAT WAS FOUND TO BE LEAKING AT THE CONNECTION POINT TO THE 5-FLUOROURACIL BOTTLE. THERE WAS A PATIENT INVOLVED, HOWEVER, NO ONE WAS HARMED AS A RESULT OF THE EVENT. THIS REPORT CAPTURES THE SECOND OF 3 INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106146 SPINNING SPIROS®, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CH2000S 4090439 00840619033903

    Patients

    Seq Age Sex Outcome Treatment
    1 ELASTOMERIC PUMP, MFR BAXTER.