BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2123013 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07601
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 10K17H25 AND 10J15H25 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE WAS NOT SURE OF THE CAUSE OF THE PERITONITIS. THE NURSE BELIEVED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. ON (B)(6) 2011, FURTHER INFORMATION WAS RECEIVED BY THE NURSE. THE NURSE REPORTED THE FOLLOWING: ON (B)(6) 2011, THE PATIENT EXPERIENCED DEHYDRATION DUE TO FLUID OVERLOAD AND WAS HOSPITALIZED THE SAME DAY. THE PATIENT WAS GIVEN FLUIDS THEN DISCHARGED (B)(6) 2011. THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THE EVENTS WERE RELATED 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 47 YR Hospitalization DIANEAL PD2 AMBUFLEX