BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 12771471 · Received November 8, 2021

    Report

    Report Number
    1416980-2021-06635
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED DURING AN UNKNOWN DATE OF (B)(6) 2021. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT WAS "CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLUTION SET", PREVIOUSLY SUBMITTED AS "UNSPECIFIED ACCESS PRIMARY SET". THE AFFECTED QUANTITY IS TWO (2) [PREVIOUSLY SUBMITTED AS ONE (1)]. D1: BRAND NAME: CLEARLINK CONTINU-FLO SOLUTION SET (PREVIOUSLY SUBMITTED AS NI) D4: CATALOGUE #: "2H8519", PREVIOUSLY SUBMITTED AS "ASKU". G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL G4: 510K #: "K961225", PREVIOUSLY SUBMITTED AS "NI". H10: THE DEVICES WERE DISCARDED 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 · 0

    IT WAS REPORTED THAT THERE WAS BACKFLOW OF INTRAVENOUS (IV) IRON THROUGH AN UNSPECIFIED ACCESS PRIMARY SET. IT WAS STATED THAT DURING THE ADMINISTRATION OF IRON IV VIA CLEARLINK SYSTEM SECONDARY MEDICATION SET THROUGH A COLLEAGUE PUMP (RATE OF 125 ML/HR), THE NURSE NOTICED THAT THE IRON WAS MOVING UP THROUGH THE PRIMARY SET. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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
    1668414 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLEARLINK SYSTEM SECONDARY MEDICATION SET| COLLEAGUE PUMP| IRON IV