BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2833612 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05231
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 12E17H25 AND 12D20H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND DIANEAL PD2 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH FORTAZ AND CIPRO. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING. ON (B)(6) 2012, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL TO HAVE THE PD CATHETER REMOVED. ON AN UNKNOWN DATE DURING THE HOSPITALIZATION, DIANEAL THERAPY WAS DISCONTINUED AND THE PATIENT BEGAN HEMODIALYSIS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS 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 62 YR Hospitalization| R HOMECHOICE| DIANEAL PD2 ULTRABAG| DIANEAL PD2 AMBUFLEX