BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11086699 · Received December 29, 2020

    Report

    Report Number
    9617594-2020-00546
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 14, 2020
    Report Date
    December 9, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE USED BAG SPIKE WITH CLAVE, LIST# UNKNOWN, LOT# UNKNOWN CONNECTED TO ONE USED LIST# CH2000S-C, SPINNING SPIROS (LOT# 4981626) CONNECTED TO ONE USED PARTIAL CUT IV SET, MANUFACTURER UNKNOWN, AND THREE NEW LIST# CH2000S-C, SPINNING SPIROS (LOT# 4981626), ONE NEW BD ALARIS PUMP SET WERE RECEIVED AND VISUALLY INSPECTED. EACH OF THE NEW SPIROS SISTER SAMPLES WERE LEAK TESTED. NO LEAKAGE OBSERVED FROM THE THREE NEW SAMPLES. THE ONE USED SPIROS SAMPLE WAS LEAK TESTED AND LEAKAGE WAS OBSERVED FROM THE POPPET TIP/MALE LUER NOSE INTERFACE. THE USED SPIROS WAS DISASSEMBLED AND DEFORMATION ON THE INTERNAL DIAMETER OF THE MALE LUER OF THE SPIROS WAS OBSERVED THAT WOULD ATTRIBUTE TO THE LEAKAGE OBSERVED. THE REPORTED COMPLAINT CAN BE CONFIRMED ON THE ONE SPIROS. THE PROBABLE CAUSE IS DUE TO AN INTERACTION BETWEEN THE CLAVE AND THE SPIROS. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4981626 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION D10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FROM SECTION E1 OF UFMW ¿ CLARISSA WELLS; PHONE #: (B)(6). ADDITIONAL CONTACT PERSON FROM SECTION F4 AND F5 OF UFMW ¿ (B)(6). ADDITIONAL INFORMATION CAN BE FOUND IN SECTION A2, A3, B3, B5, F2, AND G2.

    Description of Event or Problem · 0

    A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# 0533050000-2021-8020) WAS RECEIVED WHICH STATED: "RN ATTACHED SPIROS CAP WITH C-CLIP TO PRIMARY TUBING AND THEN CONNECTED THE END OF THE TUBING TO THE LUER LOCK (WHERE CHEMO FLUSHES ARE INSERTED). IMMEDIATELY AFTER, CHEMO BACK FLOWED THROUGH THE LUER-LOCK, SPIROS CAP AND LEAKED THROUGH THE PROXIMAL END OF THE SPIROS CAP. REGISTERED SURGICAL NURSE (RSN) WAS NOTIFIED. THE DEVICE WAS DISPOSED OF AS LEAKING CHEMOTHERAPY. THE CARE TEAM MET WITH THE MANUFACTURER REPRESENTATIVE TO REVIEW THE CASE. THIS IS ALL THE INFORMATION AVAILABLE". IT WAS ALSO REPORTED THAT THE EVENT OCCURRED AT THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED AN UNKNOWN CHEMOTHERAPY FROM THE PROXIMAL END OF SPIROS RESULTING IN THE INFUSION BEING STOPPED. THERE WAS A PATIENT INVOLVEMENT AND NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555741 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 3 YR C-CLIP, MFR ICU MEDICAL.| UNSPEC PRIMARY ADMINISTRATION SET, MFR UNK.