BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2882277 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07825
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    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 DISCOMFORT, GAS PAIN, AND BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL AND PHYSIONEAL THERAPIES FOR AUTOMATED PERITONEAL DIALYSIS (APD). IT WAS REPORTED THAT THERAPY WITH EXTRANEAL AND PHYSIONEAL WAS ONGOING. ON AN UNREPORTED DATE THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN INDICATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH FORTUM (2G, FREQUENCY NOT REPORTED) IP AND KEFLIN (2G, FREQUENCY NOT REPORTED) IP, ADDED TO EXTRANEAL DURING THE NIGHT. ON (B)(6) 2012 FORTUM WAS DISCONTINUED AND ONLY KEFLIN WAS ADDED TO EXTRANEAL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON CAPD REGIMEN. ON AN UNREPORTED DATE, AFTER THE PATIENT RETURNED HOME HE EXPERIENCED DISCOMFORT DESCRIBED AS GAS PAIN, STARTED AT THE BOTTOM OF THE STOMACH AND EXTENDED UP TO THE SHOULDERS. THIS LASTED APPROXIMATELY 30 MINUTES AFTER THE FILL. THE PATIENT EXPERIENCED NO PAIN IN CONNECTION WITH PHYSIONEAL EXCHANGES, AND PATIENT NEITHER HAD THESE PAINS DURING FILL OF EXTRANEAL WITH ADDED KEFLIN, AT THE HOSPITAL. PD NURSE EXCLUDES THAT THE PATIENT COULD HAVE INFUSED WITHOUT FIRST FLUSHING THE TUBING SET. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    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 80 YR Hospitalization| R EXTRANEAL VIAFLEX| PD CYCLER| PHYSIONEAL 35 CLEARFLEX 1.36%