BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1891573 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05297
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 11, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    PMA / PMN Number
    K063293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AN AQUALINE SET THAT HAD GOTTEN TORN DURING USE AND WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN DEFINED BECAUSE THEY WERE NOT ABLE TO DEFINE WHAT HAPPENED AND RELEVANT CAUSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM BAXTER (B)(4). THE NURSE OF THE INTENSIVE CARE DEPARTMENT AT THE UNIVERSITY HOSPITAL IN INNSBRUCK CONTACTED ON (B)(6) 2010 THE BAXTER SALES REPRESENTATIVE WITH THE FOLLOWING ISSUE: ONE HEMOFILTRATION TUBING, CODE AQUALINE WITH BATCH N10117 (NOT ACTIVE IN WISE, BATCH WAS NOT BOUGHT FROM BAXTER BY THIS CUSTOMER) GOT TORN DURING USE WITH THE AQUARIUS MACHINE. DUE TO THE FACT THAT A NURSE WAS PRESENT AT THE PATIENTS BED ONLY A SMALL AMOUNT OF BLOOD RAN OUT. THE TUBING SET WAS CHANGED IMMEDIATELY AND THE PATIENT WAS NOT HARMED. THE TREATMENT CONTINUED WITH A NEW SET WITHOUT PROBLEMS. THE SALES REPRESENTATIVE IS GOING TO VISIT THE HOSPITAL THIS WEEK AND WILL TAKE PHOTOS OF THE DEFECTIVE CONTAMINATED SET. THE SALES REPRESENTATIVE ALSO INFORMED THE LOCAL TECHNICAL SERVICE ABOUT THIS ISSUE.

    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 N10117

    Patients

    Seq Age Sex Outcome Treatment
    1