BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

    MDR report key: 2230121 · Received August 31, 2011

    Report

    Report Number
    1423500-2011-11501
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 3, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EDWARD LIFESCIENCES INFORMED BAXTER THAT NO DEFECTIVE SAMPLE WAS RECEIVED. WITHOUT AN A DEFECTIVE SAMPLE AND DETAILED INFORMATION THE ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NOT ALLEGATION AGAINST THE MACHINE OR THE DISPOSABLES. THE ONLY INFORMATION AVAILABLE WAS THE PATIENT DEATH. THE DEVICE HISTORY FILE OF THE INVOLVED LOT WAS REVIEWED WITH NO DEFECT FOUND. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS DEVICE IS DISTRIBUTED 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.

    Description of Event or Problem · 1

    THIS IS A REFERENCED COMPLAINT RAISED AGAIN THE UNKNOWN SETS INVOLVED IN THE INCIDENT BELOW. THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2010 FROM (B)(6) HOSPITAL VIA THE ACCOUNT MANAGER. IT WAS REPORTED THAT ON (B)(6) 2010 A FEMALE PATIENT PASSED AWAY WHILE RECEIVING TREATMENT ON A HEMODIALYSIS MACHINE. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT THE PATIENT WAS BEING FILTERED USING A BM25 MACHINE AND WHILE ON TREATMENT THE PATIENT PASSED AWAY. DUE TO THE NATURE OF THE PATIENT'S ILLNESS A POST MORTEM WAS REQUESTED BUT THE REPORT WAS NOT AVAILABLE. HAEMOFILTER LINES EDWARD LIFESCIENCES HAEMOFILTER LINES WERE IN USE AT THE TIME OF THE INCIDENT LINES COD (B)(4), LOT: N08305. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS KOC HAEMOTRONICS SPA N08305

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O