BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1940274 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07353
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 12, 2010
    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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. 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 AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED (DESCRIBED AS THE PATIENT MADE MISTAKE), THE PATIENT DID NOT WEAR A MASK, AND THE AREA WAS NOT CLEAN BEFORE STARTING PD. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2010, THE PATIENT RECEIVED A LOADING DOSE OF VANCOMYCIN 2 GM IP TO BE ADMINISTERED ONCE IN FIVE DAYS. ON THE SAME DAY, THE PATIENT ALSO BEGAN TREATMENT WITH MEROPENEM 1 GM IP ONCE DAILY. OUTCOME FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEANED BEFORE STARTING PD AND PERITONITIS WERE NOT REPORTED. REMEDIAL TREATMENT WITH MEROPENEM WAS ONGOING. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEANED BEFORE STARTING PD. THE REPORTER BELIEVED THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEANED BEFORE STARTING PD.

    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 49 YR Required Intervention DIANEAL PD2 ULTRABAG