BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2170384 · Received July 21, 2011

    Report

    Report Number
    1423500-2011-09245
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 23, 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR-POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM (B)(6): THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS PATIENT MADE A MISTAKE AND DID NOT WEAR A MASK. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH INJECTION REFLIN, I GRAM, ONCE A DAY, IP AND INJECTION FORTUM, 1 GRAM, ONCE A DAY, IP, BOTH OF WHICH HAD CONTINUED AS OF THE TIME OF THIS REPORT. THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT WAS RE-TRAINED THEREFORE, THE OUTCOME FOR BREAK IN ASEPTIC TECHNIQUE IS UNKNOWN. DIANEAL THERAPY WAS ONGOING. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS AND BREAK IN ASEPTIC TECHNIQUE IN RELATION TO DIANEAL 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 58 YR Required Intervention DIANEAL PD2 ULTRABAG