BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2827885 · Received November 12, 2012

    Report

    Report Number
    1416980-2012-04637
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    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 IS NOT AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED, SINCE WE ARE UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND DETERMINED THAT THE INSTRUCTIONS PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING USE ERROR - BREACH IN ASEPTIC TECHNIQUE. 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE PHILIPPINES OF A HOME PATIENT THAT DID NOT WEAR A MASK AND PERITONITIS COINCIDENT WITH DIANEAL PD2 1.5% THERAPY. DURING A CALL, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK WHILE PERFORMING PD THERAPY, WHICH CAUSED PERITONITIS. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY SLIGHTLY HAZY DRAIN. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN AND CIPROFLOXACIN (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CLOPIDOGREL| LOSARTAN| FERROUS SULFATE| CALCIUM BICARBONATE| DIANEAL PD2 1.5%| AMLODIPINE| FOLIC ACID