BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 6341618 · Received February 17, 2017

    Report

    Report Number
    1416980-2017-01393
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 17, 2017
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED TWO POTENTIALLY ASSOCIATED LOT NUMBERS: R16J08013 AND R16J18079. (B)(6). LOT NUMBER R16J18079 WAS MANUFACTURED 18 OCT 2016 - 19 OCT 2016. LOT NUMBER R16J08013 WAS MANUFACTURED 10 OCT 2016 - 11 OCT 2016. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBING WAS SEPARATED FROM THE LUER LOCK, AND THAT THERE WAS A LACK OF SOLVENT ON THE TUBE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE AN ASSEMBLY ISSUE DURING MANUFACTURING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET CAME OUT OF THE CONNECTION "CLOSE TO THE CENTER LINE PORT CONNECTOR" DURING INFUSION OF ¿MAIN LINE FLUID.¿ THIS OCCURRED WHILE THE NURSE WAS PERFORMING A LINE TRACING BY RUNNING THEIR HANDS OVER THE SET TO ENSURE IT WAS CONNECTED TO THE PROPER LOCATION. THE NURSE IMMEDIATELY CLAMPED THE TUBING TO THE PATIENT AND DISCONNECTED THE PIECE OF TUBING THAT WAS STILL CONNECTED TO THE CENTRAL LINE. 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
    121452 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CARTAGO NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR