BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 12026224 · Received June 18, 2021

    Report

    Report Number
    9617594-2021-00182
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 2, 2021
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION ON 6/28/21. ONE USED CH2000S-C SPINNING SPIROS WAS RETURNED WITH FLUID RESIDUALS VISIBLE BUT IT WAS UNABLE TO BE DETERMINED IF THE FLUID RESIDUALS WERE INSIDE OR OUTSIDE THE FLUID PATH. THERE WERE SOME FLUID RESIDUALS INSIDE THE FEMALE LUER BUT THERE WAS NO INDICATION IN THE COMPLAINT THAT THE CH2000S-C SPINNING SPIROS HAD DISCONNECTED FROM A MATING DEVICE. SUBSEQUENT TESTING AND MEASUREMENTS DID NOT REVEAL ANY LEAKAGE AND THE USED CH2000S-C SPINNING SPIROS MET PRESSURE LEAK EXPECTATIONS. THE COMPLAINT WAS UNABLE TO BE CONFIRMED OR REPLICATED DURING LAB TESTING. A DEVICE HISTORY REVIEW OF LOT# 5230116 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHICH REPORTEDLY LEAKED AT AN UNSPECIFIED LOCATION AT THE START OF PATIENT INFUSION OF CHEMOTHERAPY. THE CHEMO LEAKED ON TO THE PATIENT'S PANTS AND THE PATIENT REMOVED HIS PANTS AND RINSED HIS LEGS. THE CHEMO SPILL WAS CLEANED PER FACILITY PROTOCOL. THE SPIROS WAS REPLACED AND THE CHEMO WAS ABLE TO BE USED; THE DRUG WAS NOT REPLACED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923923 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5230116 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1