BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2890331 · Received December 29, 2012

    Report

    Report Number
    1416980-2012-08407
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. 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. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. THIS CONDITION OF A BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED, AS 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 THIS CONDITION. 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.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2012 REGARDING AN UNRELATED EVENT. PER THE PD NURSE THE HOME PATIENT (HP) WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS HOSPITALIZED AND DIAGNOSED ON (B)(6) 2012. THE NURSE STATED THAT THE PATIENT WAS NOT PERFORMING THE STEPS OF PD PROPERLY AND HAD AN ISSUE OF HAVING THE DOOR OPENED TO A ROOM, WHILE BEGINNING THERAPY. THE PATIENT WAS DISCHARGED ON AN UNKNOWN DATE IN (B)(6) 2012. DURING THE HOSPITALIZATION THE PATIENT WAS TREATED WITH ANTIBIOTIC INCLUDING VANCOMYCIN, CIPRO, AND SEPTRA (DOSE, ROUTE, AND FREQUENCY UNKNOWN). THE PATIENT WAS RETRAINED ON HOW TO PERFORM PROPER ASEPTIC PD TECHNIQUE. ALTHOUGH THE HP WAS BEING TREATED WITH SEPTRA (DOSE, ROUTE, AND FREQUENCY UNKNOWN) THE HP'S DOCTOR DECIDED TO DISCONTINUE PD THERAPY. THIS DECISION WAS DUE TO RECURRENT PERITONITIS. THE HP'S CATHETER WAS REMOVED ON (B)(6) 2012 AND THE HP WAS STARTED ON HEMODIALYSIS (HD). PER THE RN, THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. THE HP HAS REPORTEDLY RECOVERED FROM THE EPISODE OF PERITONITIS AND IS NO LONGER ON ANTIBIOTIC THERAPY.

    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 38 YR Hospitalization| R HOMECHOICE| DIANEAL LOW CA