BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2072655 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05181
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE, PYREXIA AND PERITONITIS IN A FEMALE PATIENT IN HER (B)(6) COINCIDENT WITH DIANEAL-N PD4 1.5% THERAPY. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD4 1.5% (1600ML, 4L/DAY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(6) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A FEVER OF APPROXIMATELY 37 DEGREES CELSIUS. ON (B)(6) 2011, THE NURSE PROVIDED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND PYREXIA. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE EVENT OF PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH SEFIROM (CEFTRIAXONE SODIUM HYDRATE) (DOSE, FREQUENCY AND ROUTE NOT REPORTED). IN (B)(6) 2011, THE EVENT OF PERITONITIS WAS RESOLVING. THE OUTCOME OF THE EVENTS OF PYREXIA AND BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. REMEDIAL THERAPY WITH SEFIROM WAS ONGOING. DIANEAL-N PD4 1.5% THERAPY CONTINUED UNCHANGED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD4 1.5% BECAUSE THE EVENT OF PERITONITIS WAS CAUSED BY A BREAK IN ASEPTIC TECHNIQUE. THE NURSE STATED THAT THE PATIENT HAD FORCED THE LID OF CLEAN FLASH OPEN AND PUT THE CAP ON BY HAND. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENTS OF PYREXIA AND BREAK IN ASEPTIC TECHNIQUE TO DIANEAL-N PD4 1.5%.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD4 1.5%