BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2231325 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11567
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    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 INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF POOR TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED POOR TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON (B)(6) 2011. TREATMENT WAS NOT REPORTED. THE OUTCOME FOR POOR TECHNIQUE WAS NOT REPORTED. THE PATIENT RECOVERED AND WAS DISCHARGED ON (B)(6) 2011. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THE PERITONITIS WAS CAUSED BY POOR TECHNIQUE AND NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT COMMENT ON THE EVENT OF POOR TECHNIQUE IN RELATION 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 40 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE