BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3871282 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18849
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN THE DEVELOPMENT OF PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE CAREGIVER WAS DISTRACTED WHILE SETTING UP THERAPY FOR THE PATIENT AND DID NOT US PROPER ASEPTIC TECHNIQUE. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THREE DAYS AFTER THE ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) AND GENTAMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) INTRAPERITONEALLY (IP) FOR THE EVENT. FIVE DAYS AFTER THE ONSET, THE PATIENT WAS HOSPITALIZED AS THE ABDOMINAL PAIN HAD WORSENED. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THE PERITONITIS. THE PD THERAPY WAS DISCONTINUED AND THE NURSE REPORTED THAT THE PD CATHETER WOULD BE REMOVED AT A LATER DATE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351122 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R DIANEAL 1.5% PD4 AMBUFLEX