BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1914883 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06551
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE PRODUCT USED IS UNKNOWN AND THEREFORE THE 510(K) IS UNKNOWN.

    Description of Event or Problem · 1

    PER PT 1 OUT OF 6 CONTAINERS IN ONE TOUCH ULTRA STRIPS BLUE #100, GIVING MULTIPLE ERROR MESSAGES WITH MULTIPLE ATTEMPTS, RESOLVED BY USING STRIPS FROM A DIFFERENT CONTAINER. DOSE, FREQUENCY & ROUTE USED: FOR TESTING UP TO 7 TIMES PER DAY. THERAPY DATES: (B)(6) 2010. DIAGNOSIS FOR USE: DIABETES TYPE 1.

    Description of Event or Problem · 1

    THIS IS REPORT NUMBER 3 OF 5 RECEIVED BY BAXTER (B)(4) FROM A PHYSICIAN FOR AN INCREASE IN PERITONITIS CASES AT THIS FACILITY. THE PATIENT'S DOCTOR REQUESTED AN INVESTIGATION SINCE THE NUMBER OF PERITONITIS EVENTS WAS INCREASED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FUNGAL PERITONITIS ON (B)(6) 2010 AND WAS STILL HOSPITALIZED WHEN OBTAINING THIS INFORMATION. THE PATIENT WAS TREATED WITH TRIFLUCAN 100 MILLIGRAMS INTRAVENOUSLY. THE PATIENT CONTINUED THERAPY USING HEMODIALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DEVICE (B)(4) HOMECHOICE AUTOMATED PERITONEAL DIAL