BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER

    MDR report key: 1886514 · Received October 29, 2010

    Report

    Report Number
    1423500-2010-05147
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT REFERS TO PRODUCT AQUALINE TUBING SET THAT WAS INVOLVED IN A LEAK INCIDENT. THE ACTUAL AND A COMPANION SAMPLE WERE RECEIVED. THE COMPANION SAMPLE WAS SUBJECTED TO THE FUNCTIONAL TESTING AND SHOWED THE USUAL SIGNS THAT ARE NORMALLY SEEN DURING ROUTINE TESTS FOR THE PRODUCTION BATCH RELEASE. THE ROOT CAUSE WAS NOT DETERMINED. A REVIEW OF THE DEVICE HISTORY FILE WAS PERFORMED, AND NO DEFECTS WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, AN AQUASET 12 TUBING SET, (B)(4) WAS INVOLVED IN A LEAKAGE INCIDENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT WHEN CONNECTED AND IN USE WITH AN UNIDENTIFIED PATIENT A SPLIT IN THE AQUASET LINE OCCURRED (5.5CM IN BLOOD PUMP SECTION OF LINE) THE PATIENT HAD TO BE DISCONNECTED AND A NEW LINE SET UP. THE SET HAD BEEN IN USE FOR 44 HOURS. NO PATIENT INJURY/HARM REPORTED. AN ACTUAL SAMPLE HAS BEEN RINSED AND WILL BE MADE AVAILABLE; IT WILL BE DECONTAMINATED AT (B)(6). A COMPANION SAMPLE IS ALSO AVAILABLE. SAMPLE SENT (B)(4) 2010 - (B)(4).

    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