BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK

    MDR report key: 18291498 · Received December 8, 2023

    Report

    Report Number
    1416980-2023-06405
    Event Type
    Malfunction
    Date Received
    December 8, 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H6 AND H10: H10: 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): 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.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS DID NOT FUNCTION. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. FOR THIS EVENT, THE TUBING HAS NO BACKFLOW VALVE, SO BLOOD BACKS UP IN THE CHAMBER WHEN THE BLOOD PRESSURE CUFF WAS INFLATED. THIS FREQUENTLY CREATES AN AIRLOCK AND THEN BLOOD WILL NOT FLOW UNLESS PUT UNDER PRESSURE. 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
    197517 CLEARLINK SET, BLOOD TRANSFUSION BRZ BAXTER INTERNATIONAL INC. 2C8750 ASKU 00085412046341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown