BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1991391 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01977
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    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 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. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). OUR SUPPLIER INFORMS US THAT THE DEFECTIVE SAMPLE WAS RECEIVED. EVALUATION: A VISUAL INSPECTION REVEALED THE MEMBRANE RAISED FROM THE DOME HOUSING. THE DOME ON THE VENOUS LINE, USED TO MONITOR THE RETURN PRESSURE, IS THE ONLY ONE OF FOUR DOMES ON THE LINE NOT TO BE PROTECTED FROM THE SPECIFIC CAGE. THE CONNECTION OF THE DOME WITH THE TRANSDUCER ON THE MACHINE IS "LIMITED" TO THE DETENTION TEETH ON ABS BODY AND TO THE METAL EDGE ON THE SURFACE OF THE TRANSDUCER. HOWEVER, IN NORMAL CONNECTION CONDITION OF THE DOME TO THE TRANSDUCER, ALTHOUGH NOT IN THE PRESENCE OF THE CAGE CLOSURE, MAXIMUM BLOOD PRESSURE THAT THE PUMP IS ABLE TO HANDLE IS NOT ENOUGH TO REMOVE THE DOME FROM THE TRANSDUCER. THE ONLY POSSIBILITY OF THE DOME BEING DETACHED FROM THE TRANSDUCER IS TO BE TORN ACCIDENTALLY BY TAKING IT BY ONE OF THE TWO TUBES. CONSIDERING THAT IT IS NOT PROTECTED BY THE CAGE, IT IS EASY TO CAUSE THE DETACHMENT. THE TEETH OF THE DOME ARE CLEARLY DAMAGED AND THIS IS WITHOUT EXPLANATION OF WHERE AND WHEN IN THE LIFE OF THE DEVICE, THIS DAMAGE HAS BEEN DONE . THE ROOT CAUSE WAS UNDETERMINED. THE DEVICE HISTORY FILE FOR THE INVOLVED LOT WAS REVIEWED AND NO DEFECT FOUND. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT AN AQUALINE TUBING SET WAS INVOLVED IN A RUPTURE INCIDENT. THIS OCCURRED DURING PATIENT THERAPY. NO CLINICAL EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 10294

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE