BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1873025 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04563
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    September 26, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF A PATIENT WHO DID NOT WEAR A MASK (CODED TO PERITONEAL DIALYSIS COMPLICATION) AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI. THE CAUSE OF THE PERITONITIS WAS REPORTED AS THE PATIENT DID NOT WEAR A MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND DISCHARGED ON (B)(6) 2010. ON AN UNREPORTED DATE, THE PATIENT DISCONTINUED PD THERAPY AND TRANSFERRED TO HEMODIALYSIS. IT WAS NOT REPORTED IF PD THERAPY RESUMED. OUTCOME OF BACTERIAL PERITONITIS AND PERITONEAL DIALYSIS COMPLICATION WAS NOT REPORTED. THE NURSE BELIEVED THAT THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR E. COLI WAS NOT RELATED TO PD THERAPY; THE NURSE DID NOT COMMENT ON CAUSALITY FOR PERITONEAL DIALYSIS COMPLICATION.

    Description of Event or Problem · 1

    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| O