BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2946057 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03060
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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 CAUSE CODE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A 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. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND WAS REPORTED BY THE PATIENT THAT ON AN UNKNOWN DATE IN ((B)(6) 2012? THE PATIENT EXPERIENCED THE ONSET OF PERITONITIS. FOLLOW UP WITH THE REGISTERED NURSE (RN) WAS PERFORMED, THE NURSE STATED ON AN UNKNOWN DATE IN ((B)(6) 2012) THE PATIENT WENT INTO THE HOSPITAL FOR TREATMENT AND WENT HOME THE SAME DAY. THE PATIENT WAS TREATED WITH VANCOMYCIN, IP, (DOSAGE UNKNOWN). THE RN CLARIFIED THE CAUSE OF PERITONITIS WAS TOUCH CONTAMINATION. RN STATED THAT (LAX IN PROCEDURE OR DAUGHTER WORKS IN FOOD SERVICE) WAS THE SAME AS TOUCH CONTAMINATION. THE PATIENT WAS RETRAINED ON PROPER PD THERAPY TECHNIQUE AND HAD RECOVERED. DIANEAL THERAPY WAS ON-GOING. THE RN UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50109 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization DIANEAL, HOMECHOICE