BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK

    MDR report key: 18039737 · Received October 31, 2023

    Report

    Report Number
    1416980-2023-05568
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Report Date
    June 6, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    BRZ
    UDI-DI
    00085412073583
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO: +1(203)515-6832 THE DEVICE WAS DISCARDED 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): D1: BRAND 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 AN INTERLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING RIGHT ABOVE THE CHAMBER WHERE THE BLOOD AND SALINE TUBING MEET. A SLOW TRICKLE OF BLOOD WAS SEEN SEEPING FROM THE TUBING. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP AND WAS UNKNOWN IF A PATIENT WAS INVOLVED. 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
    2129334 INTERLINK SET, BLOOD TRANSFUSION BRZ BAXTER INTERNATIONAL INC. 2C6750H ASKU 00085412073583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown