BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC

    MDR report key: 17849050 · Received September 29, 2023

    Report

    Report Number
    9615050-2023-00486
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 30, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005360
    PMA / PMN Number
    K143087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A PHOTO WAS RETURNED SHOWING LEAKAGE. NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED ON THE 124350489 PRIMARY Y-TYPE BLOOD SET FOR INSPECTION. THE PROBABLE CAUSE IS UNKNOWN. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 5973284 WAS PERFORMED AND NO RELEVANT NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH GENERATED A LEAK BETWEEN THE CONNECTION AND THE RANGER WARMING CASSETTE. SHE ADDED THAT THE LEAK WAS NOTED AFTER THE CONNECTION WAS CLEANED AND TIGHTENED WITHIN THE FIRST 5 MINUTES OF THE INFUSION. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261270 PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 5973284 10887787005360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED FLUID, UNK MFR.