BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1914800 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06527
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 COMPLAINT REFERS TO AN AQUALINE SET THAT WAS REPORTED TO HAVE A FISSURE ON THE BLOOD PUMP LINE. THE DEFECTIVE SAMPLE IS NOT AVAILABLE WITHOUT THE DEFECTIVE SAMPLE IT IS VERY DIFFICULT TO DETERMINE THE ROOT CAUSES. A DEVICE HISTORY FILE REVIEW WAS PERFORMED AND NOTHING WAS FOUND OF ANOMALOUS. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN DEFINED BECAUSE THEY WERE NOT ABLE TO DEFINE WHAT HAPPENED AND RELEVANT CAUSES.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) FROM A HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT AN AQUALINE TUBING SET WAS FOUND WITH A CUT . ACCORDING TO THE REPORTER, AFTER 4 HOURS OF DIALYSIS, THE NURSE OBSERVED AIR IN THE CIRCUIT. THEN SHE CHECKED UP THE INTEGRITY OF THE CIRCUIT TO FOUND A FISSURE ON THE BLOOD PUMP LINE. THE THERAPY HAS BEEN STOPPED. THE SET HAS BEEN DISCONNECTED AND REPLACED BY ANOTHER. THERE WAS NO INJURY OR MEDICAL INTERVENTION.

    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 N10229

    Patients

    Seq Age Sex Outcome Treatment
    1