BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11132533 · Received January 7, 2021

    Report

    Report Number
    9617594-2021-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    November 1, 2020
    Report Date
    December 11, 2020
    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
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10. NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR FOR LOT NUMBER 4991021 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) WAS ALSO SUBMITTED FOR THE SAME EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) WAS RECEIVED WHICH STATED: "CIRCLE PRIMING CHEMO AND USING SPIROS CAP. AS I WAS PRIMING THE TUBING THROUGH THE PUMP, PUMP STARTED BEEPING PARTIAL OCCLUSION AND AS I TRACED THE TUBING, NOTICED A SMALL DRIP BETWEEN THE CONNECTION END OF TUBING AND THE SPIROS CAP. GAUZE APPLIED TO SITE AND WET SPOT NOTED. AN ADDITIONAL MEDSUN MANDATORY MEDWATCH REPORT ((UF/IMPORTER REPORT# (B)(4)) WAS RECEIVED WHICH STATED: "S: BUSULFAN WAS WASTED AND HAD TO BE REMADE DUE TO LEAK ON THE UNIT. "B: NURSE ASKED PHARMACY TO REMAKE MEDICATION DUE TO LEAK. I CALLED NURSE TO CLARIFY DETAILS. SOUNDS LIKE AFTER PRIMING ON THE UNIT, MEDICATION WAS FOUND TO BE LEAKING FROM THE SPIROS (ICUMEDICAL SPINNING SPRIOS CLOSED MALE LUER RED CAP, LOT 4991021). PHARMACY REMADE AND SEND NEW BAG TO UNIT WITH A DIFFERENT SPIROS LOT NUMBER. A: UPON FURTHER INVESTIGATION AFTER SPEAKING TO NURSE, ITS SOUNDS LIKE NURSE DID NOT OUT ON A C CLIP WHILE PRIMING, WHICH LED TO LEAK OUT OF SPIROS. NURSE SAID THAT SHE WAS TOLD IT WAS OPTIONAL TO HAVE C CLIP. R: NOT SURE IF THERE WAS PREVIOUS COMMUNICATION REGARDING NOT NEEDING C CLIP,BUT THERE NEEDS TO BE FURTHER NURSING EDUCATION NOW REGARDING CIRCLE PRIMING AND C CLIPS.". THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE OUTCOME REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS EVENT OCCURRED ON AN UNSPECIFIED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31393 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4991021 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR BUSULFAN (MFR UNK).| UNK CHEMOTHERAPY (UNK MFR).