BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1920312 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06761
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 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 (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED CONSTIPATION AND A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS "DID NOT WEAR A MASK" AND "PATIENT MADE A MISTAKE." ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH REFIN (1.5GM, DAILY, IP) AND TOBRAMYCIN (60MG, DAILY, IP). THE NURSE REPORTED THAT THE PERITONITIS WAS RESOLVING. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING AS WAS REMEDIAL THERAPY WITH REFIN AND TOBRAMYCIN. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, OR IF THE EVENT OF CONSTIPATION RESOLVED. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY. THE ROOT CAUSES OF THE PERITONITIS WERE THE BREAKS IN ASEPTIC TECHNIQUE AND THE CONSTIPATION. THE NURSE DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND CONSTIPATION.

    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 53 YR Required Intervention DIANEAL PD2 ULTRABAG