BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3962006 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24511
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THE MONTH FOLLOWING THE PERITONITIS EVENT; ANTIBIOTIC THERAPY WITH CEFOTAXIME WAS DISCONTINUED. IT WAS REPORTED THAT THE PATIENT HAD BEEN ACHIEVING GOOD ULTRAFILTRATION AND HAD SIGNIFICANT RESIDUAL RENAL FUNCTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2014, THE PATIENT¿S PD EFFLUENT WAS CLEAR AND THE PATIENT DENIED ABDOMINAL PAIN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN UNSPECIFIED BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON UNKNOWN DATE (SAME MONTH AS ONSET), THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS, IP (INTRAPERITONEALLY), WITH CEFEPIME, 1GM (GRAM) DAILY FOR ONE WEEK. THREE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. ON UNKNOWN DATE (IN THE MONTH FOLLOWING ONSET MONTH) THE PATIENT WAS TREATED FOR PERITONITIS, IP, WITH CEFOTAXIME, 1GM DAILY FOR TWO WEEKS. ON AN UNKNOWN DATE THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE FOR PERFORMING PD THERAPY. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING, AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437438 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R MINICAP| DIANEAL PD4, 2.5% ULTRABAG| DIANEAL PD4, 2.5% AMBUFLEX| HOMECHOICE| MINICAP TRANSFER SET