BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1961783 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00648
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    August 27, 2010
    Report Date
    December 21, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    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 SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE WAS NOT DETERMINED. THE SUPPLIER PERFORMED A BATCH REVIEW, AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO CORRECTIVE/PREVENTATIVE ACTIONS WERE DEFINED BECAUSE THE SUPPLIER WAS UNABLE TO DEFINE WHAT HAPPENED AND THE RELEVANT CAUSES.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT DURING PREFILLING A LEAK WAS NOTICED IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS INCIDENT WAS PRIOR TO PATIENT USE AND NO PATIENT WAS CONNECTED.

    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 HAEMOTRONICS SPA B101687

    Patients

    Seq Age Sex Outcome Treatment
    1