BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER

    MDR report key: 8439262 · Received March 21, 2019

    Report

    Report Number
    9617594-2019-00096
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    February 28, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709036796
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO K7040-001 SPIROS PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR FOR LOT 3244017 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION IN CONCOMITANT MEDICAL PRODUCTS AND MFR SITE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED ON MAY 8, 2019 FOR EVALUATION. ONE (1) NEW K7040-001 SPINNING SPIROS AND ONE (1) USED K7040-001 SPINNING SPIROS WITH THE SEVERED DISTAL MALE LUER OF AN ELASTOMERIC PUMP CONNECTED WERE RETURNED. THE DEVICES WERE PRESSURE LEAK TESTED AS RETURNED AND BOTH MET PRESSURE LEAK EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE USED K7040-001 SPINNING SPIROS HAD BEEN USED WITH AN ELASTOMERIC PUMP. THE DFU STATES: TO PREVENT THE POSSIBILITY OF LEAKAGE WHEN THE SPIROS IS CONNECTED TO THE END OF AN ELASTOMERIC INFUSION PUMP, ACTIVATE THE CLAMP ON THE PUMP LINE AND/OR CONNECT THE SPIROS TO THE FEMALE PORT OF THE ELASTOMERIC PUMP IN ORDER TO MAKE A CLOSED FLUID CIRCUIT. THE LOT NUMBER OF THE RETURNED DEVICES IS 3244015. THE CUSTOMER WAS ASKED FOR CLARIFICATION AS TO WHETHER THE RETURNED SAMPLES WERE THE LOT NUMBER INVOLVED IN THE EVENT. SHE REPLIED STATING SHE HAD ASKED THE PHARMACY FOR ONE OF THE DEVICES THAT WAS CURRENTLY BEING ATTACHED TO THE INFUSOR BOTTLE. SHE TAPED IT TO THE OUTSIDE OF THE BAG CONTAINING THE USED DEVICE. SHE IS UNSURE WHY THE LOT NUMBERS ARE DIFFERENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR INVESTIGATION. IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED TWO SPINNING SPIROS CLOSED MALE LUERS ATTACHED TO AN INFUSOR BOTTLE WHICH CAUSED A SPILL OF AN UNKNOWN CHEMOTHERAPY MEDICATION WHEN THE NURSE PLACED THE BOTTLE ON THE CHAIR SIDE TABLE. THE SPILL CAME INTO CONTACT WITH THE HEALTHCARE PROVIDER¿S GLOVES, WHICH WERE IMMEDIATELY REMOVED AND THE PROVIDER¿S HANDS WERE WASHED. THE CHEMO SPILL WAS CLEANED PER FACILITY PROTOCOL, THE PRODUCT WAS REPLACED, AND THE THERAPY WAS RESUMED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, BUT THERE WAS A DELAY IN THERAPY AS ANOTHER BOTTLE HAD TO BE MIXED. THIS CAPTURES THE FIRST OF TWO DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234396 SPINNING SPIROS® CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3244017 00887709036796

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSP CHEMOTHERAPY| UNSP CHEMOTHERAPY