BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961945 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00678
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS, HYPOTENSION AND INCREASED INFLAMMATORY MARKER IN A (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL UNKNOWN BAG (LOT NUMBERS 09H06G11, 09I25G12) DURING PERITONEAL DIALYSIS. SINCE (B)(6) 2010, THE PATIENT USED CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH PHYSIONEAL 2L LOT NUMBER 09H06G11 AND EXTRANEAL. ON THE SAME DAY, THE PATIENT EXPERIENCED PERITONITIS (MANIFESTED AS CLOUDY DIALYSATE AND ABDOMINAL PAIN), HYPOTENSION AND INCREASED LABORATORY INFLAMMATORY PARAMETERS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFAZOLIN 2.5GM DAILY INTRAPERITONEALLY (IP). ON (B)(6) 2010, THE PATIENT RECEIVED PHYSIONEAL 2L WITH LOT NUMBER 09I25G12 AND EXTRANEAL (LOT NUMBER NOT REPORTED). THE REGIMEN WAS THE SAME. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH IMIPENEM 3X1GM DAILY INTRAVENOUSLY (IV), PIPRIL 3X4GM DAILY IV AND COMBACZAM 3X0.5GM DAILY IV. THE EVENTS OF PERITONITIS, HYPOTENSION AND INCREASED LABORATORY INFLAMMATORY PARAMETERS WERE RESOLVING, AND THE PHYSICIAN BELIEVED THESE EVENTS WERE UNRELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL UNKNOWN BAG THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R XIPAMIDE| RENAGEL| PHYSIONEAL| EXTRANEAL VIOFLEX| TORASEMIDE| PANTOPRAZOLE