BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1880114 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04771
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 10, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER TO INQUIRE ABOUT THE CLEAN FLASH AND STATED THAT SHE WAS IN THE HOSPITAL DUE TO PERITONITIS. THIS IS A SPONTANEOUS CASE REPORT BY A PATIENT FROM (B)(6) OF PERITONITIS IN A FEMALE PATIENT (AGE UNKNOWN) COINCIDENT WITH DIANEAL PERITONEAL DIALYSIS (PD) THERAPY. FOLLOW-UP INFORMATION RECEIVED FROM A PHYSICIAN ON (B)(6) 2010 IS AS FOLLOWS: ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 THERAPY. ON AN UNKNOWN DATE, SHE WAS HOSPITALIZED FOR PERITONITIS. IT WAS UNKNOWN IF PERITONEAL FLUID CULTURE REVEALED ANY BACTERIA. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. DIANEAL N THERAPY WAS ONGOING. ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN CONSIDERED THAT THE EVENT WAS NON-SERIOUS AND NOT RELATED TO DIANEAL N THERAPY SINCE IT WAS CONSIDERED CAUSED BY THE PATIENT'S UNSTERILIZED TECHNIQUE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD-4 1.5 THERAPY