BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2080662 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05613
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM (B)(6) OF PERITONITIS RELAPSE IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX (DIANEAL PD4 SYS II W/ 1.5% AND 2.5% GLUCOSE) AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DIANEAL PD4 SYS II W/ 1.5% AND 2.5% GLUCOSE) (12000ML, FREQUENCY AND LOT NUMBER NOT REPORTED) AND EXTRANEAL VIAFLEX (2500ML, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT CONTACTED BAXTER CUSTOMER SERVICE AND STATED THAT SHE EXPERIENCED A RELAPSE OF PERITONITIS. THE PATIENT STATED THAT THE ORIGINAL EPISODE OF PERITONITIS OCCURRED SEVERAL WEEKS AGO. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RECEIVING REMEDIAL THERAPY, IF THE EVENT OF PERITONITIS RELAPSE RESOLVED, OR WHETHER DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CONSUMER DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS RELAPSE.

    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 55 YR Other DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX