BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2161177 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-09005
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF A HEAD TO TOE RASH AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD) AND (B)(6). THIS IS ONE OF MULTIPLE REPORTS BY THE SAME REPORTER. ON (B)(6) 2011, THE PATIENT WENT TO THE (B)(6) CLINIC TO CONTINUE PD TRAINING, AND PRESENTED WITH SEVERE ITCHING DUE TO A HEAD TO TOE RASH. THE PATIENT BEGAN REMEDIAL THERAPY WITH BENADRYL (25 MG, AS NEEDED, ORALLY). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WENT TO THE EMERGENCY ROOM FOR EVALUATION. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNSPECIFIED ANTIBIOTICS (DOSES, FREQUENCIES AND ROUTES NOT REPORTED). THE NURSE REPORTED THAT THE PD THERAPY WAS ONGOING, BUT DUE TO THE HOSPITALIZATION, DIANEAL PD4 AMBUFLEX THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON FMC DELFLEX SOLUTIONS. ON AN UNREPORTED DATE, THE EVENT OF PERITONITIS HAD RESOLVED, BUT THE PATIENT REMAINED HOSPITALIZED AND ANTIBIOTICS WERE ONGOING. AT THE TIME OF THIS REPORT, THE EVENT OF RASH WAS ONGOING, BUT IMPROVED. THE NURSE CONSIDERED THE EVENTS OF HEAD TO TOE RASH AND PERITONITIS TO BE UNASSESSABLE IN RELATIONSHIP TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| BENADRYL