BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2171775 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09296
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(4) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF POOR PERITONEAL DIALYSIS (PD) PROCEDURE, TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL-N PD2 1.5% THERAPY FOR RENAL FAILURE CHRONIC. DURING A CALL TO BAXTER CUSTOMER SERVICE CENTER, THE PATIENT STATED HE HAD BEEN ADMITTED FOR PERITONITIS. UPON FOLLOW-UP, THE PHYSICIAN REPORTED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED POOR PD PROCEDURE AND TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON (B)(6) 2011. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING AND THE OUTCOME FOR THE EVENT OF POOR PD PROCEDURE AND TOUCH CONTAMINATION WAS NOT REPORTED. THE ROOT CAUSE OF THE PERITONITIS WAS POOR PD PROCEDURE AND TOUCH CONTAMINATION. DIANEAL WAS ONGOING AND UNCHANGED. THE PHYSICIAN BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL-N PD2 1.5 THERAPY, HOWEVER, DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF POOR PD PROCEDURE AND TOUCH CONTAMINATION.

    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 Hospitalization| R DIANEAL-N PD2 1.5%