BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM, CONTINU-FLOSET, 2 LUER ACTIVATED VALVES M

    MDR report key: 1760261 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01733
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLES WERE RECEIVED AND EVALUATED. DURING VISUAL INSPECTION UNDER BINOCULAR MICROSCOPE, THE TUBING WAS FOUND TO HAVE RUPTURED. THIS OCCURRED ON THE SORTIMAT SUBASSEMBLY SEGMENT. ADDITIONALLY, THERE WERE NUMEROUS SMALL CRACKS OBSERVED CLOSE TO THE RUPTURE POINT. HOWEVER, THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. MANUFACTURING DOCUMENTS WERE ALSO REVIEWED AND ALL RELEASE CRITERIA WERE WITHIN SPECIFICATION. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER.

    Description of Event or Problem · 1

    A PARAMEDIC REPORTED TO BAXTER (B)(4) PHARMACOVIGILANCE REGARDING A CLEARLINK SYSTEM CONTINU-FLO SETS IN WHICH THE THE TUBING ITSELF BROKE VERY EASILY. NO OTHER PRODUCTS STORED IN THE SAME AREA OF THE AMBULANCE APPEAR TO BE DAMAGED. THE PARAMEDIC DID NOT USE ANY OF THE TUBING. THE PROCESS STEP IS PRIOR TO USE ON PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM, CONTINU-FLOSET, 2 LUER ACTIVATED VALVES M SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST09E092

    Patients

    Seq Age Sex Outcome Treatment
    1