BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2111590 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06978
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    December 1, 2010
    Report Date
    May 13, 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). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (10E17H25, 10G15H25). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (LOT NUMBER, DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. THE PATIENT WAS NOT HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD RECOVERED FROM THE PERITONITIS AND PD THERAPY WAS ONGOING. THE OUTCOME FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    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 70 YR Other DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE