BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2223656 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11258
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 5, 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 11B10H25 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED AND 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 (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT RECOVERED. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM WAS UNRELATED TO DIANEAL THERAPY.

    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 44 YR Hospitalization HOMECHOICE| DIANEAL PD4