BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 2062769 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04694
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 3, 2011
    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 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). EVALUATION OF THE SAMPLE BY BAXTER AND HAEMOTRONIC CONFIRMED THAT THE PRESSURE DOME WAS DAMAGED AND MISSING 5 TEETH. THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT THE PRESSURE DOME (RED LINE) WAS DAMAGED WHEN REMOVING IT FROM THE OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. 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 HAEMOTRONICS SPA B101687

    Patients

    Seq Age Sex Outcome Treatment
    1