BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1812691 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02809
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 3, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) RECEIVED ON (B)(6) 2010 REGARDING A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG, LOT NUMBERS 1003089 AND 1002055, (DOSE AND FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS "THE PATIENT MADE A MISTAKE". ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON THE SAME DAY. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1 GM, LOADING DOSE, IV) AND TEZECT (4.5GM, DAILY, IV). DIANEAL THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH TEZECT. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVING. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE. THE BATCH RECORD AND ANALYTICAL RESULTS FOR DIANEAL ULTRABAG PD2 LOT NUMBERS 1003089 AND 1002055 HAVE BEEN REVIEWED AND FOUND TO BE COMPLIANT WITH THE STANDARD SPECIFICATION. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DIANEAL PD2 ULTRABAG THERAPY