BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123369 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33494
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING FOLLOW UP THAT THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT, IN THE PREVIOUS MONTH, PRIOR TO THE RECEIPT OF THIS REPORT, THE HEMODIALYSIS WAS STOPPED AND PATIENT WAS STARTED ON PERITONEAL DIALYSIS (PD) THERAPY. THE PD THERAPY WAS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A USE ERROR THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH RESULTED IN PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER SPECIFIED. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS ONSET OF THE PERITONITIS. THE PATIENT WAS TREATED WITH FORTAZ (1.5 GRAMS DAILY FOR 3 WEEKS, INTRAPERITONEALLY) AND VANCOMYCIN (1 GRAM BASED ON LABORATORY VALUES, INTRAPERITONEALLY) AND DIFLUCAN (1 DOSE OF 200 MG AND THEN 100 MG DAILY, ORALLY) FOR THE EVENT. ON AN UNKNOWN DATE IN THE SAME MONTH AS HOSPITALIZATION, THE PATIENT WAS DISCHARGED. TWELVE DAYS AFTER THE INITIAL ONSET, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND WAS AGAIN HOSPITALIZED FOR ONGOING PERITONITIS. AT THE TIME OF THIS REPORT, TREATMENT WAS ONGOING AND THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. THE PATIENT HAD NOT BEEN RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602374 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL 2.5% PD4 AMBUFLEX, EXTRANEAL| DIANEAL 4.25% PD4 AMBUFLEX