BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2051506 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04387
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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 PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PYREXIA AND PERITONITIS BACTERIAL IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND DIANEAL-N PD4 (B)(4) THERAPIES FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS BACTERIAL, MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN, AND PYREXIA. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PHYSICIAN STATED THAT THE PATIENT HAD A VISUAL IMPAIRMENT AND THERE WAS A HIGH POSSIBILITY THAT A BREAK IN ASEPTIC TECHNIQUE OCCURRED. THE PHYSICIAN ALSO STATED THAT THE PATIENT DID NOT RE-USE SUPPLIES. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECEIVED TREATMENT WITH UNSPECIFIED ANTIBIOTICS IP AND RECOVERED FROM THE PERITONITIS BACTERIAL. EXTRANEAL AND DIANEAL-N THERAPIES WERE CONTINUED AT THE SAME DOSE. THE PHYSICIAN BELIEVED THE PERITONITIS BACTERIAL WAS UNRELATED TO EXTRANEAL AND DIANEAL-N THERAPIES. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE PYREXIA IN RELATION TO EXTRANEAL AND DIANEAL-N THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD4| EXTRANEAL VIAFLEX