BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE S

    MDR report key: 2133763 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07826
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    November 24, 2009
    Report Date
    November 26, 2009
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVE AND SENT TO (B)(4) FOR FURTHER EVALUATION. THE ISSUE WAS IDENTIFIED AT AN INJECTION POINT AND WAS TESTED WITH AIR AT A PRESSURE OF 500 MMHG AND FOUND TO BE OBSTRUCTED WITH A FILM. THE FILM WAS FOUND TO BE THE CAUSE OF THE INCREASE IN PRESSURE. THE FILM WAS THE RESULT OF AN EXCESS OF SOLVENT USED FOR THE ASSEMBLY OF THE LINE. REVIEW OF THE DEVICE HISTORY FILE FOR THE INVOLVED LOT DID NOT REVEAL ANYTHING ANOMALOUS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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 RENALS RETROSPECTIVE REVIEW & REMEDIATION PROJECT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A LINE SET FOR THE AQUARIUS MACHINE COULD NOT BE INSTALLED PROPERLY AND THE MACHINE ALARMED "HIGH ARTERIAL PRESSURE" DURING PRIME. DURING INSPECTION OF THE SET, AN IMPASSABILITY WAS FOUND IN THE RED ARTERIAL LINE, IN THE PART BEFORE PRESSURE DOME OF SENSOR OF ARTERIAL PRESSURE. NO PATIENT WAS INVOLVED. ONLY ONE UNIT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUALINE S SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B083936

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS HARDWARE