BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK

    MDR report key: 18056609 · Received November 2, 2023

    Report

    Report Number
    1416980-2023-05623
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Report Date
    June 5, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    BRZ
    UDI-DI
    00085412046341
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTING THE FOLLOWING FIELDS TO ALIGN WITH THE INFORMATION PROVIDED IN THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID): D1BRAND NAME, D3 DEVICE MANUFACTURER NAME, D4: MODEL #, D4: UNIQUE IDENTIFIER (UDI) #, G4: COMBINATION PRODUCT. THE D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT/SERIAL NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET LEAKED FROM THE ACCESS PORT. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH PACKED RED BLOOD CELLS (PRBC). AFTER THE BLOOD TRANSFUSION COMPLETED, THE NURSE TRANSFER THE PRBCS TO SALINE TO FLUSH THE LINE. THE PUMP ALARMED AND THE NURSE FOUND A TUBING KINK NEAR THE PERIPHERAL INTRAVENOUS LINE (PIV) SITE. BOTH THE BLOOD AND SALINE INFUSION LEAKED OVER THE BED AND PATIENT. THE NURSE INSPECTED THE TUBING; BLOOD AND SALINE BACKED UP AND LEAKED FROM THE ACCESS PORT WHEN THE TUBING KINKED. THE PIV LINE WAS FLUSHED AND INTACT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889595 CLEARLINK SET, BLOOD TRANSFUSION BRZ BAXTER INTERNATIONAL INC. 2C8750 ASKU 00085412046341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PIV SITE.| PRBC.| SALINE.| UNSPECIFIED PUMP.