BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2060342 · Received April 16, 2011

    Report

    Report Number
    1423500-2011-04608
    Event Type
    Injury
    Date Received
    April 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL, UNKNOWN, AND PHYSIONEAL, UNSPECIFIED PRODUCT, (LOT NUMBERS NOT REPORTED) THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN, 2 BAGS, AND PHYSIONEAL, UNSPECIFIED PRODUCT, 1 BAG (FREQUENCY AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH ROCEFIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED). AT THE TIME OF THIS REPORT, THE PERITONITIS WAS NOT RESOLVED, THE PATIENT REMAINED HOSPITALIZED AND TREATMENT WITH ROCEFIN CONTINUED. THE ACTION TAKEN WITH DIANEAL AND PHYSIONEAL THERAPIES WAS UNKNOWN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN BELIEVED THE EVENT OF PERITONITIS WAS RELATED TO DIANEAL THERAPY. HOWEVER, THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS IN RELATION TO PHYSIONEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R DIANEAL| PHYSIONEAL