BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3955819 · Received July 24, 2014

    Report

    Report Number
    1416980-2014-24094
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. THIS IS A REPORT OF A USE ERROR THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS PATIENT MADE MISTAKE AND DID NOT WEAR A MASK DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. TWO DAYS AFTER THE ONSET, THE PATIENT WAS TREATED WITH INJECTIONS OF CEFTAZIDIME (1 GRAM, TWICE DAILY, INTRAPERITONEALLY (IP)) AND INJECTIONS OF VANCOMYCIN (2 GRAM, ONCE DAILY, IP) FOR PERITONITIS. THE TREATMENT WITH THE ANTIBIOTICS WAS ONGOING. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434937 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIANEAL 2.5% PD2 ULTRABAG.