BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE

    MDR report key: 2133731 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07814
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT A BLOOD LEAK IN AN AQUALINE THAT OCCURRED DURING PATIENT INFUSION. THE SERIAL NUMBER WAS UNKNOWN. THERE WAS A SPLIT IN THE LINESET TUBING AROUND THE BLOOD PUMP. BLOOD WAS INSTANTLY NOTICED AROUND THE BLOOD PUMP AND THE PATIENT IMMEDIATELY DISCONNECTED WITHOUT WASHING BACK. THE LINESET WAS DISCARDED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1