BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3900461 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20673
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT WAS BORN ON AN UNREPORTED DATE IN 1997. (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS DUE TO A BREACH IN ASEPTIC TECHNIQUE. THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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 ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. ON THE SAME DAY AS ONSET, THE PT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFAZOLIN (INTRAPERITONEALLY (IP), 2G, DAILY) AND GENTAMYCIN (IP, 80MG, DAILY) FOR THE PERITONITIS. TREATMENT WITH THESE ANTIBIOTICS WAS DISCONTINUED AND THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (IP, 1G, DAILY) AND AMIKACIN (IP, 300MG, DAILY). THE PATIENT DID NOT RESPOND TO THIS TREATMENT AND THEIR PD CATHETER WAS REMOVE. THE PATIENT WAS THEN PLACED ON HEMODIALYSIS. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT THE PT WAS STILL HOSPITALIZED AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377529 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5% ULTRABAG| DIANEAL PD4 1.5% ULTRABAG