BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2002552 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02510
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 7, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, THE PATIENT RECEIVED BY INJECTION VANCOMYCIN, 2 GRAM LOADING DOSE IP , INJECTION OF AMIKACIN, 10 MG ONCE DAILY IP, AN INJECTION OF FORTUM, 1 GM ONCE DAILY AND BY INJECTION HEPARIN 1000 IU THREE TIMES A DAY, WHICH HAD CONTINUED. AT OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND THE PERITONITIS WAS RESOLVING. IT WAS REPORTED THAT THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. DIANEAL THERAPY CONTINUED. THE CONSUMER BELIEVED THE PERITONITIS WAS UNRELATED TO PD THERAPY, AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R DIANEAL PD2 ULTRABAG