BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1860026 · Received October 7, 2010

    Report

    Report Number
    1423500-2010-04110
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED TO BAXTER FOR EVALUATION. SHOULD THE SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FOLLOWING ARE THE RESULTS OF THE MANUFACTURER'S EVALUATION: A SEGMENT OF THE PUMP TUBING WAS RECEIVED AS DEFECTIVE SAMPLE FOR EVALUATION. THE SAMPLE SHOWS A CUT ABOUT 1 CM LONG. ALONG THE SAME LINE OF THE CUT THERE ARE TWO CLEAR MARKS OF ABRASION ON THE SURFACE OF THE TUBE. CUT AND ABRASIONS ARE POSITIONED APPROXIMATELY IN THE MIDDLE OF THE PUMP SEGMENT. THE MARKS OF ABRASION PRESENT ON THE TUBE NEAR THE CUT INDICATE THAT THE TUBE WAS SUBJECTED TO A MECHANICAL ACTION DIFFERENT FROM THE STANDARD CRUSHING CAUSED BY THE ROTOR OF THE MACHINE. THE CRUSH OF THE TUBE CAUSED BY THE ROTOR IN STANDARD CONDITIONS IS DISTRIBUTED ON ALL THE LENGTH OF THE TUBE. THE MANUFACTURER DID NOT PROVIDE THE ROOT CAUSE OF THIS INCIDENT. ACCORDING TO THE MANUFACTURER, A DESIGN HISTORY REVIEW OF THE LOT INVOLVED IN THIS INCIDENT FOUND NO ISSUES RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2010 FROM (B)(6) HOSPITAL TO THE ACCOUNT MANAGER. ON (B)(6) 2010 AN AQUALINE TUBING WAS INVOLVED IN A LEAK INCIDENT. DURING PATIENT USE. THE PATIENT HAD BEEN TREATED FOR APPROXIMATELY EIGHT HOURS ON THE AQUARIUS MACHINE. THE NURSE NOTICED THAT THE PATIENT'S BLOOD PRESSURE WAS DROPPING. IT WAS THEN THAT THEY NOTICED BLOOD LEAKING FROM THE LINE IN THE BLOOD PUMP HOUSING. TREATMENT WAS STOPPED AND THE SET WAS TAKEN DOWN. THE LOCAL IN HOUSE ENGINEER WAS CONTACTED AND HE LOOKED AT THE MACHINE HE THEN CONTACTED A BAXTER SALES MANAGER WHO ADVISED HIM NOT TO USE THE MACHINE UNTIL IT WAS SEEN BY A BAXTER ENGINEER. THE PATIENT WAS HAEMODINAMICALLY UNSTABLE DUE TO THE NATURE OF HIS CONDITION, BUT NO OTHER ADVERSE EFFECTS WERE REPORTED.

    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 N 10 117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other