BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1904993 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05998
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE PRODUCT USED IS UNKNOWN AND THEREFORE THE 510(K) ENTRY FIELD IS LISTED AS NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    BAXTER'S GLOBAL PHARMACOVIGILANCE (GPV) COMMUNICATED THAT DURING A PHONE CONVERSATION WITH THE PERITONEAL DIALYSIS (PD) NURSE, THE FOLLOWING INFORMATION WAS OBTAINED. ON (B)(6) 2010, THE PATIENT DEVELOPED PASTEURELLA MULTOCIDA PERITONITIS. THE PATIENT WAS TREATED WITH A THREE WEEK REGIMENT OF ORAL (PO) AUGMENTIN (DOSAGE AND FREQUENCY WERE NOT REPORTED). AT THE TIME OF THE REPORT, THE PERITONITIS WAS ONGOING, BUT IMPROVED. THE NURSE STATED THE PERITONITIS WAS CAUSED BECAUSE THE PATIENT'S CAT HAD BIT THE PD LINE AND IT WAS NOT RELATED TO THE DIANEAL AND EXTRANEAL SOLUTIONS OF THE HOMECHOICE DEVICE. FURTHER INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE OTHER MESSAGE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention