BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER

    MDR report key: 1886478 · Received October 29, 2010

    Report

    Report Number
    1423500-2010-05141
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 30, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER RECEIVED ONE UNUSED COMPANION SAMPLE. A VISUAL INSPECTION OF THE PUMP SEGMENT WAS PERFORMED FINDING THAT IT WAS IN COMPLIANCE WITH SPECIFICATIONS. A FUNCTIONAL TEST WAS ALSO PERFORMED SETTING THE LINE ON A MACHINE USING THE PARAMETERS NORMALLY USED FOR THE RELEASE OF THE PVC PUMP SEGMENT AFTER PRODUCTION: - FLOW: 450 ML/MIN (MAXIMUM FLOW ALLOWED BY THE MACHINE) - ROLLING TIME : 80 HOURS - WATER TEMPERATURE: 37 DEGREES CELSIUS. AT THE END OF THE TEST, THE PUMP SEGMENT WAS CHECKED, FINDING CLEAR LINES DUE TO THE SQUASHING OF THE TUBE, NO ABNORMAL ABRASION ON THE SURFACE OF THE TUBE, AND NO CUT OR TEARING. THE COMPANION SAMPLE WAS RECEIVED AND TESTED ACCORDING TO THE FUNCTIONAL TESTS NORMALLY USED FOR THE RELEASE OF THE PUMP SEGMENT, SHOWING THE STANDARD SIGN OF USE BUT NO ABRASION AND/OR CUT/TEARS. A BATCH REVIEW WAS COMPLETED FOR THE LOT INVOLVED WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2010 FROM (B)(6) VIA (B)(6). IT WAS REPORTED THAT ON (B)(6) 2010, AN AQUASET TUBING SET WAS INVOLVED IN A LEAKAGE INCIDENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT WHEN CONNECTED TO AN UNIDENTIFIED PATIENT, THERE WAS LEAKAGE FROM THE BLOOD PUMP AREA OF THE TUBING SET RESULTING IN THE PATIENT HAVING TO BE DISCONNECTED FROM THE AQUARIUS MACHINE. THE SET HAD BEEN IN USE FOR 5 HRS. NO PATIENT INJURY/HARM REPORTED. NO ACTUAL SAMPLE WAS MADE AVAILABLE. A COMPANION SAMPLE IS AVAILABLE.

    Description of Event or Problem · 1

    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 N10116

    Patients

    Seq Age Sex Outcome Treatment
    1