BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASET

    MDR report key: 2133868 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07844
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    March 12, 2010
    Report Date
    March 13, 2010
    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 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. THE SAMPLE WAS RECEIVED FOR INVESTIGATION AT THE MANUFACTURING SITE. THE SAMPLE WAS TESTED AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE CHECK-VALVE AT THE END OF THE HEPARIN LINE WAS FOUND TO BE WORKING CORRECTLY. THE CLAMP WAS IN COMPLIANCE WITH THE SPECIFICATION. THERE WERE NO DEFECTS FOUND THAT MAY HAVE COMPROMISED THE FUNCTION. THE DEFECTIVE SAMPLE DID NOT SHOW ANY ANOMALY OR DEFECT. TESTS PERFORMED INTERNALLY, DEMONSTRATED THAT THESE CLAMPS CORRECTLY CLOSED, AND WERE ABLE TO OCCLUDE THE HEPARIN TUBE. THE ROOT CAUSE FOR THE INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) TO REPORT BLOOD HAVING SPRAYED FROM THE AQUALINE SET. NO HEPARIN WAS ATTACHED TO THE END OF ANTICOAGULATION LINE, THE LINE WAS STILL COILED FROM THE FACTORY, THE ORIGINAL BUNG WAS ON THE END OF THE LINE, AND THE CLAMP WAS ON. THE PATIENT HAD COUGHED AND BLOOD SPRAYED OVER THE FRONT OF THE MACHINE FROM THE ANTICOAGULANT LINE EVEN THOUGH THE CLAMP WAS ON. THE PATIENT AND THE NURSE WERE NOT IN CONTACT WITH THE BLOOD. THE NURSE WAS ADVISED TO DISCONTINUE USE OF THE AQUALINE SET AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. A SECTION OF THE ACTUAL SAMPLE WAS RECEIVED, AS WELL AS A COMPANION SAMPLE, HOWEVER THIS SAMPLE HAD A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B094250

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS HARDWARE