BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1872542 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04482
    Event Type
    Death
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE IS NO 510K NUMBER SINCE THE LOT NUMBER AND PRODUCT CODE ARE UNKNOWN. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS AVAILABLE.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER FROM THE CUSTOMER AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5L BAG. THE REPORTER STATES THAT WHILE A PATIENT WAS RECEIVING HAEMODIAFILTRATION THERAPY ON AN AQUARIUS MACHINE USING THE ABOVE SOLUTION, DURING A CHECK ON THE PROGRESS OF THERAPY WHICH WAS 39 HRS AFTER COMMENCEMENT OF THERAPY, IT WAS NOTICED THAT THE DIALYSATE LINE WAS FULL OF AIR AND CRYSTALLIZED PARTICLES. THE PARTICLES WERE SMALL ALMOST LIKE BUBBLES IN ALL OF THE 4 BAGS THAT WERE ATTACHED TO THE MACHINE AND ALSO VISIBLE IN THE ENTIRE REPLACEMENT SOLUTION SIDE. NO PATIENT INJURY HAS BEEN REPORTED / CONFIRMED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A (B)(6) NURSE RECEIVED A CALL FROM A FEMALE PATIENT'S FAMILY REQUESTING PICK UP OF THE DEVICE AND SUPPLIES AS THE PATIENT HAD EXPIRED. THIS WAS A FEMALE PATIENT IN HER (B)(6) RECEIVING DIANEAL PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6)2010, SHE EXPIRED. THE CAUSE OF DEATH WAS IDENTIFIED AS GEROMARASMUS (EMACIATION DUE TO OLD AGE). DIANEAL N AND EXTRANEAL WERE ONGOING UNTIL THE TIME OF DEATH. MEDICAL HISTORY INCLUDED RENAL FAILURE CHRONIC, RHEUMATISM AND MULTIPLE CEREBRAL INFARCTS. THE NURSE BELIEVED THAT THE FATAL EVENT WAS NOT RELATED TO DIANEAL N AND EXTRANEAL THERAPIES. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death DIANEAL-N PD-4 2.5 AND EXTRANEAL THERAPIES