BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1850519 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03990
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER INDICATED THAT A DEVICE HISTORY FILE OF THE INVOLVED LOT WAS PERFORMED WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT RECEIVED FROM THE (B)(6) BY BAXTER (B)(4). ON (B)(6) 2010 A BAXTER RENAL SALES MANAGER CONTACTED CORPORATE QUALITY ASSURANCE (CQA) REPORTING THE OCCURRENCE OF AN INCIDENT WITH AN AQUALINE (LINE SET FOR THE AQUARIUS MACHINE, LOT NUMBER UNKNOWN). THE REPORTING PHYSICIAN INDICATED THAT AN ADULT MALE PATIENT WAS CONNECTED TO THE AQUARIUS MACHINE, AND AFTER 65 HOURS OF CONNECTION, THE PHYSICIAN VISUALLY DETECTED A BLOOD LEAK IN THE ARTERIAL LINE, IN THE SEGMENT OF THE BLOOD PUMP. IT WAS REPORTED THAT THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE SAMPLE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINE SET FOR AQUARIUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI HAEMOTRONICS SPA N1022

    Patients

    Seq Age Sex Outcome Treatment
    1