BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 2022325 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03290
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BAXTER ( 765 )SWITZERLAND SA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED , AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT COULD NOT BE CONFIRMED DURING BAXTER AND HAEMOTRONIC'S SAMPLE EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BECAUSE THE COMPLAINT COULD NOT BE CONFIRMED, ROOT CAUSE COULD NOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT AFTER PREFILLING, A LEAK WAS FOUND IN THE EFFLUENT LIQUID TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINE SET FOR AQUARIUS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK BAXTER ( 765 )SWITZERLAND SA B101688

    Patients

    Seq Age Sex Outcome Treatment
    1