BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1862306 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04225
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 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 PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND RECURRENT PERITONITIS IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, AND THE PATIENT DEVELOPED PERITONITIS. THE PHYSICIAN STATED THAT THE PATIENT HAD REPEATED EPISODES OF PERITONITIS, MANY TIMES, BECAUSE HE COULD NOT MANAGE TO KEEP ASEPTIC TECHNIQUE. INFORMATION REGARDING THE ONSET DATE, OUTCOME, TREATMENT AND DIAGNOSTIC TESTING FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND RECURRENT PERITONITIS WERE NOT REPORTED. THE ROOT CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS DISCONTINUED DUE TO THE REPEATED EPISODES OF PERITONITIS AND LACK OF MANAGEMENT TO KEEP ASEPTIC TECHNIQUE. THE PHYSICIAN DID NOT REPORT IF THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND RECURRENT PERITONITIS WERE RELATED TO PD THERAPY.

    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 DIANEAL-N PD4 1.5