BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    MDR report key: 17546168 · Received August 14, 2023

    Report

    Report Number
    9615050-2023-00326
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 1, 2023
    Report Date
    May 20, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887709100128
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED SEVEN (7) USED 140019291 PRIMARY PLUM SETS FOR INSPECTION FROM LOT NUMBERS 11286729, 6359741, 11286729, 52302217, 7884749, 5603775, AND 786677 FOR EVALUATION ON 8/8/2023. NO DEFECTS OR ANOMALIES NOTED. EACH SET WAS ATTACHED TO AN ICU MEDICAL PROVIDED IV BAG, PRIMED PER PACKAGING DIRECTIONS AND A FLOW TEST WAS PERFORMED USING AN ICU PLUM PUMP. THERE WERE NO DIFFICULTIES IN PRIMING, NO CASSETTE ERRORS, NO OCCLUSION ALARMS WERE GENERATED, NO AIR IN LINE ALARMS WERE GENERATED AND NO RESTRICTIONS IN FLOW WERE OBSERVED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED ON THE REPORTED ONE (1) USED 140019291 PRIMARY PLUM SET LOT# 11286729. HOWEVER, THE ONE (1) USED 140019291 PRIMARY PLUM SET LOT# 6359741 CAN BE CONFIRMED BASED ON A LOT HISTORY REVIEW - CORRECTIVE ACTIONS ARE IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT IS YET TO BE RECEIVED. D1 FULL BRAND NAME: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 272 CM.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 272 CM IN WHICH THE CUSTOMER REPORTED THAT THE DEVICE HAD AN ONGOING DISPLAY OF "PROX OCCLUSION A STARTUP- OPEN/CLOSE DOOR OR BACKPRIME" NOTIFICATIONS. THE INFUSION WAS REPORTED TO STOP MID TREATMENT DISPLAYING A NOTIFICATION OF "POWER OFF THEN ON ¿ REPLACE PUMP IF ALARM CONTINUES". THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55488 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 11286729 10887709100128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown