BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2882404 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07845
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER. A BATCH REVIEW WAS CONDUCTED ON POTENTIAL LOTS H12C30049 AND H12G09010 WHICH REVEALED NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE. THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION FOR THIS PERITONITIS CASE. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE SPOKE TO THE REGISTERED NURSE ON (B)(6) 2012 IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THE HOSPITALIZATION THAT WAS STATED IN AN UNRELATED REPORT. THE NURSE REPORTED THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2012 WITH CLOUDY EFFLUENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH PERITONITIS ON (B)(6) 2012. THE CAUSE FOR THE PERITONITIS IS UNKNOWN BY THE NURSE. PERITONEAL EFFLUENT SAMPLES WERE OBTAINED ON (B)(6) 2012. THE PATIENT WAS TREATED WITH VANCOMYCIN 1.5 G INTRAPERITONEALLY (IP) EVERY OTHER DAY FOR 2 WEEKS. THE PATIENT WAS RETRAINED ON HOW TO PERFORM PERITONEAL DIALYSIS THERAPY USING PROPER ASEPTIC TECHNIQUE DESPITE NOT KNOWING THE CAUSE OF THE PERITONITIS. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2012 AND IS CONSIDERED TO BE RECOVERING FROM THIS EPISODE OF PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL