BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER

    MDR report key: 1925295 · Received December 14, 2010

    Report

    Report Number
    1423500-2010-06865
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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). 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. THE SAMPLE WAS REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AN AQUALINE SET THAT HAD TUBING DAMAGE AND WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN DEFINED BECAUSE THEY WERE NOT ABLE TO DEFINE WHAT HAPPENED OR THE RELEVANT CAUSES.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4). IT WAS REPORTED THAT AN AQUARIUS BLOOD LINE SET WAS INVOLVED IN A DAMAGED TUBING INCIDENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT WHILE IN USE, THE BLOOD PUMP SECTION OF TUBING TORE DOWN THE LENGTH AROUND THE PUMP AND BLOOD WENT EVERYWHERE. THE PATIENT WAS DISCONNECTED AND DID NOT SUFFER ANY CONSEQUENCES. THEY WERE SET UP ON ANOTHER MACHINE AND MONITORED THE BLOOD PUMP AREA OF TUBING AND NOTICED A TEAR APPEARING AGAIN. NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE