BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10927213 · Received December 1, 2020

    Report

    Report Number
    9617594-2020-00517
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 19, 2020
    Report Date
    November 19, 2020
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RECEIVED ONE NEW LIST #CH2000S-C,SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT #5000438, ONE NEW LIST #CH2000S-C,SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT #4991020,ONE USED LIST #CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP; LOT #UNKNOWN. EACH OF THE RETURNED SAMPLES WERE PRESSURE LEAK TESTED AS PER PERFORMANCE SPECIFICATION AND USING AN AUXILIARY TEST AND EACH MET LEAK EXPECTATIONS WITHOUT LEAKAGE AT ANY LOCATION ALONG THE FLUID PATH. THE COMPLAINT OF LEAKAGE WAS UNABLE TO BE REPLICATED OR CONFIRMED IN THE NEW CH2000S-C SPINNING SPIROS SAMPLES RETURNED. THERE WERE FLUID RESIDUALS NOTED OUTSIDE THE FLUID PATH OF THE USED CH2000S-C SPINNING SPIROS SO LEAKAGE OF CAN BE CONFIRMED FROM THE PHOTO BUT THE PROBABLE CAUSE OF THE LEAKAGE COULD NOT BE DETERMINED SINCE IT PASSED PRODUCT PERFORMANCE AND AUXILIARY LEAK TESTING. A DEVICE HISTORY REVIEW (DHR) LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED FOR THE ONE USED SAMPLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION; IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED LEAKING PEMETREXED. THE CUSTOMER REPORTED LEAKING 10 SECONDS AFTER THE INFUSION WAS STARTED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT, AND NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395506 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 PEMETREXED, MFR UNK| PEMETREXED, MFR UNK