BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 10977737 · Received December 9, 2020

    Report

    Report Number
    1416980-2020-07668
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 10, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412071107
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET POTENTIALLY CAUSED AN ALARM. DURING AN UNSPECIFIED INFUSION VIA A BAXTER SIGMA PUMP, AN ERROR 324 (COLOR SENSOR ERROR: FRQ) ALARMED. THE SET WAS TESTED ON THREE SEPARATE PUMPS; AND ALL THREE PUMPS ALARMED THE ERROR 324. 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
    1442361 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R20D24073 00085412071107

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER SIGMA PUMP| UNSPECIFIED SOLUTION