BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2173803 · Received July 24, 2011

    Report

    Report Number
    1423500-2011-09357
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER 10K17H25 WITH NO EXCEPTIONS OR ISSUES OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. 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. THIS IS A SPONTANEOUS CONSUMER REPORT FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CONSUMER WAS NOT SURE, BUT THOUGHT THE DOCTOR HAD TOLD HIM THAT THE PERITONITIS WAS CAUSED BY E. COLI. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED TO HAVE THE PD CATHETER REMOVED AND WAS DISCHARGED THE SAME DAY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. ON AN UNREPORTED DATE IN 2011, DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN AND THE PATIENT SWITCHED TO HEMODIALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other HOMECHOICE| DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX