BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF KIT F.AQUARIUS W/HF12AQUAMAX FILTER

    MDR report key: 1904870 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05970
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT SAMPLE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. 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). THE SAMPLE WAS RECEIVED IN A VERY BAD CONDITION, IT WAS IMPOSSIBLE TO MANAGE THE SAMPLE AND EVALUATE IT. THE DESCRIPTION OF THE COMPLAINT DOES NOT HELP TO UNDERSTAND THE PROBLEM. THE DEVICE HISTORY FILE WAS REVIEWED BUT THEY DIDN'T FIND ANY ANOMALOUS. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(6) FROM A PHARMACIST . IT IS REPORTED THAT A PATIENT EXPERIENCED A BLOOD LEAK WHILE HE WAS TREATED THROUGH AN AQUASET 12 DEVICE. A BLOOD LEAKAGE WAS OBSERVED AT THE LEVEL OF THE BLOOD PUMP LINE. THE THERAPY WAS STOPPED AND THE PATIENT WAS THEN RECONNECTED TO A NEW CIRCUIT. THE LINE WAS CHECKED AND NO KINKS WERE FOUND. THE BLOOD PUMP WAS CHECKED AND IT WAS FINE AS WELL. A NEW SET WAS THEN CONNECTED ON THE SAME MACHINE AND PERFORMED CORRECTLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED FOR THE PATIENT.

    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 B094940

    Patients

    Seq Age Sex Outcome Treatment
    1