BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN

    MDR report key: 17398163 · Received July 26, 2023

    Report

    Report Number
    9615050-2023-00270
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 5, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT HOWEVER A PHOTO HAS BEEN PROVIDED AND IS PENDING INVESTIGATION. THE CUSTOMER PROVIDED POSSIBLE LOT NUMBERS MFR DATE AND EXPIRATION DATE LOT 7876764 MANUFACTURE DATE 10/1/2022 EXPIRATION DATE 10/1/2025 . LOT 5935516 MANUFACTURE DATE 07/1/2022 EXPIRATION DATE 7/1/2025. LOT 8909729 MANUFACTURE DATE 10/1/2022 EXPIRATION DATE 10/1/2025 . ADDITIONAL REPORTER INFORMATION : A-STRONG CO., LTD. (B)(6) - PRODUCT MANAGER (B)(6).

    Additional Manufacturer Narrative · 0

    TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER. IN PHOTO ONE (1) THE PUMP HAD THE ERROR "N230 PROXIMAL AIR BACKPRIME" ALARM DISPLAYED. THE DRIP CHAMBER APPEARED TO BE NEARLY EMPTY OF FLUID. NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT CAN BE CONFIRMED. 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.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM SET WHERE IT WAS REPORTED THAT DURING INFUSION OF NORMAL SALINE, THEY WERE UNABLE TO INFUSE PROPERLY AFTER 3MIN OF INFUSION. THERE WAS NO OBVIOUS DEFECTS NOTED ON THE TUBING SET SUCH AS CRACKS OR BREAKS WITH NO ANY HOLE, CUT, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WAS NOT EXPOSED IN EXTREME TEMPERATURE CONDITION. THERE WAS NO FLOW IN THE PRIMARY LINE WITH NO ANY DAMAGE NOTED SUCH AS OCCLUSIONS, OR KINKS, OR BENDS. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645054 PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NORMAL SALINE, MFR UNK