BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2033569 · Received March 30, 2011

    Report

    Report Number
    1423500-2011-03835
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF ASEPTIC PERITONITIS, DIARRHEA, FEVER, DETERIORATION OF THE GENERAL STATUS, FATIGUE AND BRONCHOPNEUMOPATHY IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES FOR CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS). THE NURSE REPORTED THAT DURING THE NIGHT "FROM (B)(6) 2011" THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2011, THE PATIENT EXPERIENCED ASEPTIC PERITONITIS AFTER THE USE OF NUTRINEAL, AND EXTRANEAL. THE PATIENT WAS HOSPITALIZED FOR ASEPTIC PERITONITIS AND DETERIORATION OF THE GENERAL STATUS. UPON ARRIVAL TO THE HOSPITAL, THE PATIENT PRESENTED WITH A FEVER OF 37.7 DEGREES C, ABDOMINAL PAIN, DETERIORATION OF THE GENERAL STATUS, FATIGUE AND FIBRIN IN THE EFFLUENT BAG. ON (B)(6) 2011, THE PATIENT'S FEVER IN THE MORNING WAS 38.6 DEGREES C. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (DOSE AND FREQUENCY NOT REPORTED) IP, THEN VANCOMYCIN AND OFLOCET (OFLOXACINE) (DOSE AND FREQUENCY NOT REPORTED) IV. THE OFLOCET WAS ADMINISTERED UNTIL DAY 4. ON AN UNREPORTED DATE, THE PATIENT WAS "SWITCHED" FIRST TO GENTAMYCIN, AND THEN THE PATIENT RECEIVED AUGMENTIN (AMOXICILLIN/CLAVULANIC ACID). INFORMATION PERTAINING TO CONTINUATION OF REMEDIAL TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED. THE OUTCOME FOR THE EVENT OF ASEPTIC PERITONITIS AND FEVER WERE REPORTED AS NOT RECOVERED. THE OUTCOME FOR THE EVENTS OF DIARRHEA, DETERIORATION OF THE GENERAL STATUS, AND FATIGUE WERE NOT REPORTED. ON AN UNREPORTED DATE, NUTRINEAL AND EXTRANEAL WERE "STOPPED." THE NURSE REPORTED THE PATIENT CONTINUED CAPD WITH "ISO AND HYPER FROM FRESENIUS." THE NURSE REPORTED THAT SHE "SUSPECTED" THE EVENTS OF ASEPTIC PERITONITIS, DIARRHEA, FEVER, DETERIORATION OF THE GENERAL STATUS, AND FATIGUE WERE POSSIBLY RELATED TO NUTRINEAL AND EXTRANEAL THERAPY. THE REPORTER DESCRIBED THE ASEPTIC PERITONITIS AS MODERATE AND FURTHER DESCRIBED IT AS "PERITONITIS IN A PATIENT SUFFERING FROM SEVERAL PATHOLOGIES." THE PHYSICIAN BELIEVED THE EVENT OF ASEPTIC PERITONITIS WAS RELATED TO NUTRINEAL THERAPY AND UNRELATED TO EXTRANEAL THERAPY. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BRONCHOPNEUMOPATHY TO NUTRINEAL AND EXTRANEAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R EXTRANEAL VIAFLEX| NUTRINEAL PD4 UNKNOWN BAG| ISO AND HYPER FROM FRESENIUS