BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 8740255 · Received June 27, 2019

    Report

    Report Number
    9617594-2019-00199
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 7, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - DATE RETURNED TO MFG: 6/17/2019. H10: THREE NEW LIST # CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT #S 4040740, 3988371, AND 4032452 WERE SENT FOR INVESTIGATION. TESTING AND INVESTIGATION WERE PERFORMED WITHOUT ANY ISSUES NOTED. TESTING WAS NOT ABLE TO REPLICATE THE PROBLEM OF LOOSE CONNECTION AND LEAKAGE BETWEEN THE SYRINGE AND THE SPIROS. THE RETURNED PRODUCTS DID NOT LEAK. THE POSSIBLE AFFECTED LOTS WERE LOT # 4040740, 3988371, AND 4032452. LOT REVIEWS WERE PERFORMED WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A CUSTOMER ALLEGATION AGAINST SPINNING SPIROS CLOSED MALE LUER THAT DISCONNECTED FROM END OF LARGE VOLUME PUMP TUBING, BUT STAYED ATTACHED TO MICROCLAVE ON PATIENT'S CENTRAL LINE. THIS OCCURRED DURING INFUSION OF CYTARABINE AND DAUNORUBICIN AND WAS LEAKING FROM PATIENT'S LINE. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF AN ADVERSE EVENT OR HUMAN HARM AND NO REPORT OF DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535486 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 CYTARABINE.| DAUNORUBICIN.| CYTARABINE| DAUNORUBICIN