BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1953368 · Received January 8, 2011

    Report

    Report Number
    1423500-2011-00313
    Event Type
    Malfunction
    Date Received
    January 8, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BAXTER ( 765 )SWITZERLAND SA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. EVALUATION OF THE SAMPLE BY BAXTER FOUND THAT THERE WAS A HAIR IN THE DRIP CHAMBER, THUS CONFIRMING THE COMPLAINT. HOWEVER, BECAUSE, THE SAMPLE WAS CONSIDERED TO BE CONTAMINATED, IT COULD NOT BE SENT TO HAEMOTRONIC FOR FURTHER EVALUATION. BECAUSE HAEMOTRONIC COULD NOT EVALUATE THE SAMPLE, NO ROOT CAUSE COULD BE CONCLUSIVELY DETERMINED. ACCORDING TO HAEMOTRONIC'S INVESTIGATION REPORT, A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS THE RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED THAT DURING PREFILLING, THE NURSE NOTED THERE WAS A HAIR IN THE FILTER NET OF THE DRIP CHAMBER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    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 BAXTER ( 765 )SWITZERLAND SA B103384

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE