BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2022561 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03307
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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 GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER REPORTED THE FOLLOWING. IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. UPON A FOLLOW UP CALL WITH THE PATIENT'S NURSE, THE NURSE STATED THAT THERE WAS NO RECORD OF DIAGNOSIS OF PERITONITIS OR PD EFFLUENT CULTURE PERFORMED IN (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED SYMPTOMS OF PERITONITIS. THE PATIENT WAS TREATED WITH IP VANCOMYCIN (DOSE, FREQUENCY UNREPORTED), AND WAS NOT HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011, THE PATIENT HAD A CLOUDY BAG. THIS EVENT WAS CONSIDERED A RECURRENT/ RELAPSED PERITONITIS, WHICH WAS TREATED WITH IP VANCOMYCIN (DOSE, FREQUENCY UNREPORTED). ON (B)(6) 2011, THE LAST DOSE OF VANCOMYCIN WAS GIVEN. ON (B)(6) 2011, PD THERAPY WAS WITHDRAWN AND THE PD CATHETER WAS REMOVED. ON (B)(6) 2011, THE PATIENT STARTED TEMPORARY HEMODIALYSIS (HD). THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR BACILLUS WAS UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention DIANEAL PD4 AMBUFLEX