BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2882349 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07841
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE. ON AN UNREPORTED DATE, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH CEFAZOLIN (26G, DAILY FOR 9 DAYS, IP) FOR PERITONITIS UNTIL (B)(6) 2012. THE CAUSE OF PERITONITIS WAS CONSIDERED TO BE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. THE NURSE STATED THE PATIENT IS NOT DOING THE DIALYSIS ON HER OWN. A COMMUNITY PERITONEAL DIALYSIS (PD) NURSE IS HELPING THE PATIENT WITH HER DIALYSIS. SHE ALSO SAID THAT THEY ARE FOLLOWING UP WITH THE PATIENT, AND THERE HAVE NOT BEEN ANY PROBLEMS SO FAR. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT OF USE ERROR-BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS WAS CONFIRMED, BECAUSE IT WAS REPORTED BY THE NURSE THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR PERITONITIS -NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS AND URINARY TRACT INFECTION IN A PATIENT COINCIDENT WITH DIANEAL 1.5%, DIANEAL 2.5% AND EXTRANEAL THERAPIES. ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THIS WAS THE FIRST EPISODE OF PERITONITIS FOR THIS PATIENT AND THE MICROBIAL MICROORGANISM WAS UNKNOWN. ON AN UNREPORTED DATE WHILE IN THE HOSPITAL, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED. TREATMENT FOR THE PERITONITIS AND URINARY TRACT INFECTION WAS NOT REPORTED. THE OUTCOME OF THESE EVENTS IS UNKNOWN. THE EVENT OF PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS.

    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 Hospitalization| R EXTRANEAL PD2 7.5%| DIANEAL PD4 2.5%| DIANEAL PD4 1.5%