BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970751 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01033
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 6, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM THE (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT WITHOUT ABDOMINAL PAIN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2GM, 2 DOSES GIVEN, ROUTE NOT REPORTED) AND A FIVE DAY COURSE OF CIPROFLOXACIN (500MG, TWICE DAILY, ROUTE NOT REPORTED). REMEDIAL THERAPY WITH CIPROFLOXACIN WAS DISCONTINUED ON (B)(6) 2010. THE NURSE REPORTED THAT VANCOMYCIN WAS DISCONTINUED ON (B)(6) 2010. ON AN UNREPORTED DATE, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPY WERE WITHDRAWN. THE NURSE REPORTED THAT THE PATIENT IMPROVED WITH THE DISCONTINUATION OF PD SOLUTIONS. THE NURSE REPORTED THAT PD SOLUTIONS WERE NOT REINTRODUCED. THE NURSE REPORTED THAT THE EVENT OF STERILE PERITONITIS WAS ONGOING AND IMPROVED. THE NURSE CONSIDERED THE EVENT OF STERILE PERITONITIS TO BE RELATED EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention EXTRANEAL VIAFLEX AND NUTRINEAL PD4