BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE

    MDR report key: 2110551 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06911
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 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 THE SUPPLIER CONFIRMED THAT THERE WAS A BLACK SPOT ON THE INSIDE OF THE TUBING. THE SUPPLIER FURTHER EVALUATED THE SAMPLE AND DETERMINED THAT THE SPOT WAS NOT PARTICULATE MATTER INSIDE THE TUBING; RATHER IT A HALO ON THE TUBING. BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE ROOT CAUSE WAS UNDETERMINED. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT WHEN TAKING THE BLOOD LINES OUT OF THE PACKAGE THERE WAS A BLACK SPOT NOTICED ON THE TUBING. 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 AQUALINE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B104818

    Patients

    Seq Age Sex Outcome Treatment
    1