BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 8027480 · Received November 1, 2018

    Report

    Report Number
    9617594-2018-00152
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 18, 2018
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNING FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED WITHOUT THE RETURNED SAMPLE. A DEVICE HISTORY REVIEW (DHR) WAS COMPLETED AND NO NON-CONFORMANCES WERE NOTED. CONCOMITANT MEDICAL PRODUCT: MAXPLUS NEEDLELESS CONNECTOR, MFR BECTON, DICKINSON AND COMPANY; THERAPY DATE: (B)(6) 2018. 45" EXTENSION SET WITH A/S VALVE, LN AMS 435CV-1, LOT NUM: 1806004D, MFR: VYGON; RAPIDFILL CONNECTOR, LN H93813901, LOT #: 60123404, MFR BAXTER; 600CC SYRINGE, MFR BECTON, DICKINSON AND COMPANY, THERAPY DATE: UNKNOWN.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT A LEAK OF FLUROURACIL-5FU WAS NOTICED ON AN AMBULATORY PUMP SETUP THAT WAS IN USE FOR 46 HOURS. THE SPIROS WAS ATTACHED TO A MAXPLUS NEEDLELESS VALVE. IT WAS REPORTED THERE WAS NOTICEABLE WHITE RESIDUE POWDER IN/ON THE SPIROS AND OUTSIDE OF THE MAXPLUS-SPIROS CONNECTION. THE CUSTOMER REPORTED THAT THE CASSETTE RESERVOIR WAS PREPARED IN THE PHARMACY USING A VYGON EXTENSION SET TO THE CASSETTE AND PRIMED MANUALLY WITH A BAXTER RAPIDFILL CONNECTOR AND A BECTON, DICKINSON 600CC SYRINGE; POSSIBLE MISALIGNED CONNECTION WITH RAPIDFILL CONNECTOR AND SPIROS BEING FULLY ENGAGED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENTS, NO MEDICAL OR SURGICAL INTERVENTIONS PROVIDED AND NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867895 SPINNING SPIROS CLOSED MALE LUER, RED CAP SPINNING SPIROS FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CH2000S-C 3761680 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1