BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET,CLEARLINK CONTINU-FLO 3YLL 106 IN 10DPM 48 EA/CA

    MDR report key: 1941529 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06363
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF TWO CLEARLINK CONTINU-FLO SETS IN WHICH THE DRIP CHAMBERS DOES NOT FILL ONCE THE SETS ARE SPIKED INTO THE SOLUTION BAG. THE PROCESS STEP IN WHICH THIS REPORTED CONDITION OCCURRED IS PRIOR TO PATIENT-USE. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET,CLEARLINK CONTINU-FLO 3YLL 106 IN 10DPM 48 EA/CA SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST10D073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION BAG