BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11065212 · Received December 23, 2020

    Report

    Report Number
    9617594-2020-00545
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 3, 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
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS WERE PROVIDED AND EVALUATED. ONE IMAGE SHOWED A SPINNING SPIROS CONNECTED TO AN UNKNOWN EXTENSION SET AND A CADD PUMP CASSETTE. NO VISIBLE DAMAGE OR ANOMALIES WERE IDENTIFIED IN THE PHOTO. ONE USED LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP (LOT# 4981626), ONE USED UNKNOWN EXTENSION SET, AND ONE USED CADD PUMP CASSETTE WERE RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, THE SPIN FEATURE WAS ACTIVATED AND SPINNING FREELY. THE SPIROS WAS RETURNED SECURELY CONNECTED TO THE EXTENSION SET. NO VISIBLE DAMAGE OR ANOMALIES WERE SEEN ON ANY OF THE PROVIDED SAMPLES. THE SPIROS WAS FUNCTIONALLY TESTED AND FOUND TO MEET PRODUCT PERFORMANCE SPECIFICATIONS. NO LEAKAGE WAS OBSERVED. THE REPORTED COMPLAINT OF A LEAKING SPIROS COULD NOT BE REPLICATED OR CONFIRMED. A DEVICE HISTORY REVIEW (DHR) LOT# 4981626 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED LEAKING OF A UNSPECIFIED CHEMOTHERAPY. THE CUSTOMER STATED THE PATIENT'S SON SAID THAT THE PATIENT WENT TO LAY DOWN AND NOTICED HER BRA AND TEE SHIRT WERE WET WHEN SHE GOT UP. THE PATIENT WAS INSTRUCTED TO COME TO THE HOSPITAL SO THE NURSES COULD TROUBLE SHOOT. THE PATIENT'S TEGADERM AROUND THE PORT WAS COMING LOOSE AND WAS WET UNDER AND AROUND THE PORT SITE. THE TAPE SEEMED INTACT. THE TUBING WAS CLAMPED AND DISCONNECTED FROM THE PORT, THE SKIN WAS WASHED AROUND THE SITE WITH SOAP AND WATER. THE LINE WAS FLUSHED WITH 10 ML OF NORMAL SALINE AND A BLOOD RETURN WAS NOTED. IT WAS FLUSHED WITH 50 UNITS OF HEPARIN/5ML, THE LINE WAS CLAMPED, AND THE TEGADERM WAS REINFORCED AROUND IT. THE CHEMOTHERAPY WAS STOPPED AND A NEW CHEMOTHERAPY CASSETTE, TUBING, AND SPIROS WERE ATTACHED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528705 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4981626 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1