BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1811744 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02787
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 5, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ROOT CAUSE FOR THE PERITONITIS IS UNDETERMINED AS NO SAMPLE WAS AVAILABLE FOR EVALUATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A MALE PATIENT WHILE RECEIVING PERITONEAL DIALYISIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND THE PATIENT WAS NOT HOSPITALIZED. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY REMEDIAL THERAPY FOR THE PERITONITIS. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN AND PD THERAPY WAS ONGOING. THE REPORTING CONSUMER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY. .

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 ULTRABAG THERAPY