BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2212730 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10748
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. IT IS IN THE OPINION OF THE NURSE THAT THE ROOT CAUSE OF THE PERITONITIS WAS CHRONIC CONSTIPATION AND LOOSE MOTIONS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF CHRONIC CONSTIPATION, LOOSE MOTION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CHRONIC CONSTIPATION AND LOOSE MOTION. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS CHRONIC CONSTIPATION AND LOOSE MOTION. ON (B)(6) 2011, THE PATIENT RECEIVED A LOADING DOSE OF VANCOMYCIN 1 GM IP AND AMIKACIN 125 MG IP EVERY OTHER DAY (OD) WHICH CONTINUED AS TREATMENT FOR THE EVENT OF PERITONITIS. AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED AND THE EVENT OF PERITONITIS WAS RESOLVING WHILE THE OUTCOME FOR THE EVENTS OF CHRONIC CONSTIPATION AND LOOSE MOTION WERE UNKNOWN. DIANEAL THERAPY CONTINUED WITH DOSE UNSPECIFIED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE SUSPECT PRODUCT. A CAUSALITY ASSESSMENT WAS NOT PROVIDED FOR THE EVENTS OF CHRONIC CONSTIPATION AND LOOSE MOTION.

    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 71 YR Hospitalization| R DIANEAL PD2 ULTRABAG