BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2220791 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11114
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: H11D11089 AND H11C10067 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS NURSE REPORT FROM THE USA OF PATIENT THAT MADE A MISTAKE WITH TOUCH CONTAMINATION (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WHICH RESULTED IN PERITONITIS ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE WITHDRAWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6). THE OUTCOME OF THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS UNRELATED TO DIANEAL THERAPIES. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX