BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970539 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-00999
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 31, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR-POOR ASEPTIC TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A MALE PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL-N PD2 2.5% THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD2 2.5% 2.5 LITERS TWICE A DAY (LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR RENAL FAILURE CHRONIC. ON (B)(6) 2010, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT HE HAD DEVELOPED PERITONITIS AND THE EVENT WAS IMPROVING. ON (B)(6) 2010, THE PHYSICIAN PROVIDED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. THE PHYSICIAN STATED THAT THE PATIENT DEVELOPED PERITONITIS ON (B)(6) 2010. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DOSE, FREQUENCY AND ROUTE NOT REPORTED). THE OUTCOME FOR THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PERITONITIS HAD RESOLVED. DIANEAL-N THERAPY CONTINUED UNCHANGED. THE PHYSICIAN STATED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    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 Required Intervention DIANEAL-N PD2 2.5% THERAPY