BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIKE WITH BONDED CLAVE® CONNECTOR

    MDR report key: 21434080 · Received February 21, 2025

    Report

    Report Number
    9617594-2025-00330
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    October 21, 2024
    Report Date
    March 25, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619026011
    PMA / PMN Number
    K082836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    A PHOTO WAS RETURNED SHOWING THE DRIP CHAMBER OF THE CS-53. SOME PARTICULATE WAS OBSERVED IN THE DRIP CHAMBER. NUMEROUS PARTICULATES WERE OBSERVED IN THE IV BAG THAT THE BAG SPIKE WAS INSERTED INTO. THE SOURCE OF THE PARTICULATE IS BELIEVED TO BE FROM THE INFUSATE IN THE IV BAG AND NOT TO BE A DEFECT IN THE ICU MEDICAL DEVICE. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE IS UNKNOWN BUT IS UNRELATED TO THE CS-53. LOT HISTORY REVIEW COULD NOT BE PERFORMED DUE TO THE UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A SPIKE WITH BONDED CLAVE® CONNECTOR. PARTICLES AND WHITE DEPOSITS WERE REPORTED IN THE DRIP CHAMBER (BUT WERE NOT VISIBLE IN VIALS/BAGS) WHEN THE DEVICE WAS USED WITH CYCLOPHOSPHAMIDE. THIS CAUSED THE PUMP TO ALARM DURING A PATIENT'S INFUSION AT THE HDJ ONCOLOGY/URC UNIT. TREATMENT NEEDED TO BE DISCONTINUED AS A NEW BAG NEEDED TO BE PREPARED AND RECONNECTED FOR TREATMENT. THE CYCLOPHOSPHAMIDE MANUFACTURER HAS BEEN NOTIFIED AND THEY WILL CONDUCT TESTS TO IDENTIFY A POSSIBLE INCOMPATIBILITY. THE CUSTOMER ADDED THAT THE PUMP USED DURING INFUSION WAS A VOLUMAT PUMP AND NO ISSUES WERE OBSERVED WITH THE PUMP. THE MEDICATION USED WAS A TO BE DILUTED BEFORE INJECTION VIAL OF CYCLOPHOSPHAMIDE 1000MG/2 ML FROM REDDY PHARMA. THERE WERE NO HOLES, CUTS, TEAR OR ANY OTHER DEFECT WITH THE SPIKE, THE PATIENT WAS STABLE, NO ONE WAS HARMED DURING THE INCIDENT, ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED, THERE WAS NO BLOOD LOSS, THERE WAS A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634523 SPIKE WITH BONDED CLAVE® CONNECTOR STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00840619026011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CYCLOPHOSPHAMIDE FROM REDDY PHARMA, STRENGTH 1000M.| VOLUMAT PUMP, MFR UNK.