BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK

    MDR report key: 22161789 · Received June 6, 2025

    Report

    Report Number
    1416980-2025-03239
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 7, 2025
    Report Date
    July 7, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412080956
    PMA / PMN Number
    K153158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT #: CUSTOMER PROVIDED A SUSPECT LOT# R24J23079. D4: EXPIRATION DATE (SUSPECT LOT): 10/24/2029. D4: UNIQUE IDENTIFIER (UDI) # (SUSPECT LOT): (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H4, H6, AND H11: H4 (SUSPECTED LOT): THE SUSPECTED LOT WAS MANUFACTURED BETWEEN OCTOBER 25, 2024. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THE SUSPECTED LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 CONTINU-FLO SOLUTION SET LEAKED FROM ONE OF THE Y-SITES WHILE BEING USED WITH A CLEARLINK SYSTEM NON-DEHP EXTENSION SET. THIS OCCURRED DURING A PATIENT INFUSION OF AMIODARONE AT A RATE OF 33 ML/HR, WHICH HAD BEEN RUNNING FOR LESS THAN SIX HOURS. THE NURSE OBSERVED A PUDDLE OF FLUID UNDER THE INTRAVENOUS (IV) POLE. THE SET WAS LEAKING FROM THE FIRST PORT DOWNSTREAM FROM NOVUM IQ LARGE VOLUME PUMP. ADDITIONALLY, AS THE PATIENT ARM WAS EXTENDED, THE NURSE NOTICED BLOOD BACKING UP FROM THE SITE OF INSERTION TOWARD THE FILTER EXTENSION SET. 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
    604431 CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2H8671 R24J23079 00085412080956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMIODARONE| CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET| IV POLE| NOVUM IQ LVP