BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 8730822 · Received June 25, 2019

    Report

    Report Number
    1416980-2019-03424
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    March 20, 2018
    Report Date
    August 2, 2019
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED BETWEEN DECEMBER 10, 2018 - DECEMBER 11, 2018. 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)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 06/17/2019: THE DATE OF THE EVENT: ONE EVENT OCCURRED ON 03/20/2018 CORRECTION: IT WAS INITIALLY REPORTED THERE WERE THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET NO FLOWS. AFTER RECEIVING ADDITIONAL INFORMATION THIS REPORT REMAINS FOR ONE CLEARLINK DEVICE. ADDITIONAL INFORMATION RECEIVED 06/17/2019: THE LOT# FOR THE ONE EVENT ON 03/20/2018: R18L08017 : DUE TO THE ADDITIONAL INFORMATION RECEIVED ON 6/17/2019 THE OTHER 2 DEVICES WILL BE SUBMITTED IN MDR 1822660/MFR# 1416980-2019-03800 (WITH DATE OF EVENT 05/15/2019 AND LOT# R19B20078) AND IN MDR 1822661/MFR#1416980-2019-03799 (WITH DATE OF EVENT 05/15/2019 AND LOT# R19A29147). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO FLOW OF MEDICATION THROUGH A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THE LINE PRIMED EASILY, BUT ONCE PRIMED WOULD NOT DRIP VIA GRAVITY OR VIA PUMP. THE ISSUE WAS RESOLVE BY REPLACING THE SET WITH A NEW SET. THERE WAS NO 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
    524511 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CARTAGO NA R18L08017

    Patients

    Seq Age Sex Outcome Treatment
    1