BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1981141 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01623
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 16, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY, INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL TREATMENT INCLUDING VANCOMYCIN 2 GRAMS IP AS A LOADING DOSE AND TOBRAMYCIN 80 MG IP ONCE DAILY. THE ROOT CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. THE OUTCOME OF THE PERITONITIS WAS REPORTED AS UNKNOWN. DIANEAL PD2 AMBUFLEX THERAPY CONTINUED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIANEAL PD2 AMBUFLEX