BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3050246 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08915
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO PATIENT DID NOT WEAR MASK. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD. ON AN UNKNOWN DATE, THE PT EXPERIENCED A DROP IN WEIGHT FROM 73 KILOGRAMS TO 66 KILOGRAMS, DEHYDRATION, AND LOW BLOOD PRESSURE. ON AN UNREPORTED DATE, THE PT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS PT DID NOT A WEAR MASK. SUBSEQUENTLY, THE PT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT OF PERITONITIS AND DEHYDRATION. THE PT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY, AND ROUTE NOT REPORTED) FOR PERITONITIS. TREATMENT FOR THE DEHYDRATION WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. IT WAS REPORTED THAT THE PT WOULD BE USING YELLOW BAGS (DIANEAL 1.5%) UNTIL THE WEIGHT AND BLOOD PRESSURE COME BACK UP. TWO DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PT WAS DISCHARGED. ON AN UNREPORTED DATE, THE PT RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT RECEIVED RE-TRAINING IN PROPER STERILE TECHNIQUE COVERING THE CONCEPT OF CLEAN AND DIRTY (DETAILS NOT PROVIDED) AND RECEIVED A TRAINING HOME VISIT BY A PD NURSE. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149930 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX, LOW CALCIUM