BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2922919 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01426
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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 BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF A PATIENT (PT) THAT MADE A MISTAKE/TOUCH CONTAMINATION, MYCOBACTERIAL INFECTION AND INFECTIOUS PERITONITIS COINCIDENT WITH DIANEAL THERAPIES. ON AN UNREPORTED DATE, THE PT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED MYCOBACTERIAL INFECTION AND INFECTIOUS PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS REPORTED AS THE PT MADE A MISTAKE/TOUCH CONTAMINATION. ON AN UNREPORTED DATE, THE PATIENT STARTED UNSPECIFIED ANTIBIOTICS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ) HEPARIN INTRAPERITONEALLY (IP), DOSE AND FREQUENCY NOT REPORTED), INJ FORTUM (1GM, IP AND FREQUENCY NOT REPORTED) AND INJ VANCOMYCIN (1GM, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27714 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R DIANEAL