BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2336209 · Received November 14, 2011

    Report

    Report Number
    1423500-2011-14952
    Event Type
    Injury
    Date Received
    November 14, 2011
    Date of Event
    August 1, 2011
    Report Date
    October 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    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 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)(6) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH BIEFFE FORMULAE 55 THERAPY FOR CHRONIC KIDNEY FAILURE (CKF) AS AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS CONSIDERED LIFE-THREATENING. ON AN UNREPORTED DATE IN 2011, RENAL TREATMENT CHANGED TO CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE CAUSE OF THE PERITONITIS WAS BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, REMEDIAL THERAPY BEGAN WITH CEFACIDAL (CEFAZOLINE) (2G, 4 TIMES PER DAY, IP). ON (B)(6) 2011, REMEDIAL THERAPY WAS INTERRUPTED. ON (B)(6) 2011, REMEDIAL THERAPY RESTARTED WITH CEFACIDAL (CEFAZOLINE). ON (B)(6) 2011, THE PATIENT RECOVERED AND ENDED REMEDIAL THERAPY. BIEFFE FORMULAE 55 THERAPY WAS ONGOING AT THIS TIME. THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO BIEFFE FORMULAE 55 THERAPY, HOWEVER WAS RELATED TO BREAK IN ASEPTIC TECHNIQUE. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF A BREAK IN ASEPTIC TECHNIQUE WITH RELATIONSHIP TO BIEFFE FORMULAE 55 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 64 YR Life Threatening| R NPH INSULIN| APROVEL| LOXEN LP| PD CYCLER| INSULIN (ISULINE)| BIEFFE FORMULAE 55 , LOXEN LP, APROVEL, INSULIN (I