BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2241443 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11960
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CANADA PHARMACOVIGILANCE FOLLOWED UP AND SPOKE WITH THE PATIENT. THE PATIENT WAS HOSPITALIZED IN MORTON PLANT HOSPITAL IN FLORIDA AT THE TIME OF THE CALL (REASON UNSPECIFIED). NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CUSTOMER FROM (B)(6) OF PERITONITIS/ANTIBIOTICS. INITIALLY THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE (TS) CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THE TS REPRESENTATIVE ASSISTED THE HOME PATIENT (HP) TO END THE THERAPY AS REQUESTED. THE HP WAS TO FOLLOW UP WITH THE REGISTERED NURSE (RN) REGARDING ENDING THE THERAPY EARLY. DURING THE COURSE OF THE CONVERSATION IT WAS REPORTED THAT ON AN UNREPORTED DATE, THE HP HAD ACQUIRED PERITONITIS AND WAS ON ANTIBIOTICS. THERE WAS NO FURTHER INFORMATION PROVIDED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED 5L BAG| UNSPECIFIED 2.5L BAG