BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1953394 · Received January 9, 2011

    Report

    Report Number
    1423500-2011-00327
    Event Type
    Malfunction
    Date Received
    January 9, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AN AQUALINE SET THAT WAS DAMAGED/DEFORMED. THE COMPLAINT WAS NOT CONFIRMED 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 AND RELEVANT CAUSES.

    Description of Event or Problem · 1

    THIS IS A CASE THAT WAS REPORTED TO A BAXTER TECHNICAL SERVICES SUPERVISOR. THE CUSTOMER REPORTED THAT DURING THE FIRST 5 MINUTES OF THE PATIENT BEING CONNECTED TO THE AQUARIUS MACHINE, A NURSE NOTICED THAT THE BLOOD TUBING SET IN BLOOD PUMP WAS MISSHAPED (FLAT) AND THE HEPARIN SYRINGE HAD INFUSED MORE THAN EXPECTED. THE PATIENT WAS DISCONNECTED AND THE AQUARIUS DEVICE WAS PUT INTO RECIRCULATION MODE. THE NURSE THEN CLOSED THE HEPARIN LINE AND REMOVED THE SYRINGE AND NOTED 15 ML HAD INFUSED, WHILE THE SCREEN RECORDED ONLY 1 ML HAD INFUSED. A BLOOD SAMPLE TAKEN FROM PATIENT WHICH CONFIRMED AN INCREASED LEVEL OF HEPARIN, BUT DID NOT CAUSE INJURY TO THE PATIENT.

    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 B101688

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE