BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1950010 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00161
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. 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

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD1 1.36%, DIANEAL PD1 2.27% AND NUTRINEAL PD4 UNKNOWN BAG (2L, DAILY) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) SUBSEQUENT TO LIGHT CHAIN GLOMERULOPTHAY WITH INTERSTITIAL NEPHRITIS. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY A FEELING OF PRESSURE WITHIN HER ABDOMEN AND CLOUDY PERITONEAL EFFLUENT. ON THE SAME DAY, THE PATIENT RECEIVED REMEDIAL THERAPY WITH HEPARIN (1000 IE). ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFTAZIDIM (1G, DAILY, IP), AND CEFAZOLIN (1G, DAILY, IP). ON (B)(6) 2010, THE PATIENT STOPPED THERAPY WITH DIANEAL PD1 AND NUTRINEAL PD4 AND SWITCHED TO PHYSIONEAL UNKNOWN. AS OF (B)(6) 2010, THE PATIENT WAS RECOVERING FROM THE EVENT OF FEELING OF PRESSURE WITHIN ABDOMEN AND STERILE PERITONITIS. ON AN UNREPORTED DATE THE PATIENT WAS ADDITIONALLY TREATED WITH REMEDIAL THERAPY OF VANCOMYCIN (5G, EVERY 5 DAYS, IP) AND GENTAMYCIN (60MG, DAILY, IP). THE PHYSICIAN STATED THAT THE EVENTS OF FEELING OF PRESSURE WITHIN ABDOMEN AND STERILE PERITONITIS WERE RELATED TO DIANEAL PD1 AND NUTRINEAL PD4 THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SIMVASTATIN HEUMANN, OMEP, VALETTE, CALCET| AMLODIPIN-CT, TORASEMID HEXAL, ARANESP| DIANEAL PD1 1.36% (2L, TWICE DAILY)| NUTRINEAL PD4 UNKNOWN BAG (2L, DAILY)| RESTEX RETARD, EINSALPHA, FERINJECT, CYTOBION 1000| DIANEAL PD1 2.27% (2L, DAILY)| RAMIPIRIL BETA, METROPROLOSUCCINATE 1A PHARMA