BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3790856 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14511
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED A PATIENT (PT) EXPERIENCED AND WAS HOSPITALIZED THE SAME DAY ((B)(6) 2014) FOR REPEAT BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, NAUSEA AND CLOUDY EFFLUENT. THE PD REGISTERED NURSE (RN) STATED IT WAS THE SAME PERITONITIS SINCE (B)(6) 2014 AND THAT THE PT HAD NOT FULLY RECOVERED FROM THE (B)(6) 2014 EPISODE OF PERITONITIS; THEREFORE, THE CAUSE REMAINS A BREACH IN ASEPTIC TECHNIQUE. THE SAME DAY THE PT WAS HOSPITALIZED, THE PT WAS TREATED WITH INTRAPERITONEAL VANCOMYCIN (3 GRAMS EVERY 5 DAYS, ONGOING). THE PT WAS DISCHARGED THREE DAYS AFTER ADMISSION. AT THE TIME OF THIS REPORT THE PT WAS RECOVERING FROM THIS PERITONITIS EVENT. THE PT HAS NOT BEEN RETRAINED YET, BUT HAD BEEN RE-TRAINED "MANY TIMES BEFORE". NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE FOLLOWING DAY THE PT WAS HOSPITALIZED FOR THE EVENT FOR 2 DAYS. IN THE SAME MONTH AS THE ONSET OF THE EVENT, THE PT WAS TREATED WITH VANCOMYCIN, INTRAVENOUS (IV) AND IP (3 GRAMS, 3 TIMES PER WEEK FOR 1 MONTH) FOR PERITONITIS. TWO DAYS LATER, THE PT WAS READMITTED TO THE HOSPITAL FOR THE SAME PERITONITIS EVENT. FIVE DAYS LATER, THE PT WAS DISCHARGED. ON AN UNREPORTED DATE THE FOLLOWING MONTH, THE PT WAS RE-TRAINED ON ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM PERITONITIS AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266403 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R DIANEAL PD4 1.5% AND 2.5% AMBUFLEX, EXTRANEAL