BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123274 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33484
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY WHICH CAUSED PERITONITIS MANIFESTED AS ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS PATIENT DID NOT WEAR A MASK WHILE PERFORMING PD (PERITONEAL DIALYSIS) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS ONSET, THE PATIENT BEGAN TREATMENT FOR PERITONITIS WITH CEFAZOLIN IP-INTERPERITONEALLY (2 GRAMS EVERY 2 DAYS). THREE DAYS AFTER ONSET, THE PATIENT RECOVERED FROM THE ABDOMINAL PAIN AND CLOUDY FLUID. AT THE TIME OF THIS REPORT, CEFAZOLIN THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING FROM THE PERITONITIS, AND DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602716 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL PD4, 1.5% & 2.5% AMBULEX.