BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 10410614 · Received August 14, 2020

    Report

    Report Number
    1416980-2020-04985
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT IS CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET, PREVIOUSLY SUBMITTED AS UNSPECIFIED CHEMOTHERAPY SET. D1: BRAND NAME: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE#: 2C8541, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: LOT# R20D30013, PREVIOUSLY SUBMITTED AS ¿ASKU¿. D4: UNIQUE IDENTIFIER (UDI) #: (B)(4), PREVIOUSLY SUBMITTED AS ¿NI¿. G1: THE DEVICE MANUFACTURES INFORMATION IS BAXTER HEALTHCARE ¿ CARTAGO, PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION. G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL. G5: PMA/510K #: K961225 PREVIOUSLY SUBMITTED AS ¿NI¿. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED CHEMOTHERAPY SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THIS ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEP. 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
    873337 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R20D30013

    Patients

    Seq Age Sex Outcome Treatment
    1