BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2061131 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04631
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS IS REPORT 1 OF 3 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS IS BEING INVESTIGATED IN MANUFACTURER REPORT 1423500-2011-04627.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE RECEIVED A REPORT OF PERITONITIS FROM A HOME PATIENT'S (HP) NURSE. THE NURSE REPORTED THE HP WAS HAVING PAIN, CRAMPING, AND A BURNING SENSATION WHILE PERFORMING THERAPY. PRODUCT SURVEILLANCE OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE NURSE: THE HP HAD RECENTLY HAD THEIR CATHETER SURGERY AND BEGAN PD THERAPY ON (B)(6) 2011. PRIOR TO THAT, THE NURSE WAS JUST DOING MANUAL FLUSHES AND LEAVING A SMALL AMOUNT OF SOLUTION IN. THE NURSE WAS FLUSHING THE CATHETER AND STOPPED DUE TO THE HP HAVING PAIN. THE NURSE THOUGHT THE CRAMPING MAY HAVE BEEN DRAIN PAIN AND PLACED THE HP ON TIDAL THERAPY, WHICH HELPED WITH THE CRAMPING. THE HP HAS BEEN ABLE TO INFUSE ABOUT 2000ML. WHEN THE NURSE HAD THE HP INFUSE 2500ML THE PAIN STARTED AGAIN. THE PATIENT WENT BACK ON HEMODIALYSIS FOR A TOTAL OF FOUR TREATMENTS AND THEN RESUMED THERAPY ON THE CYCLER ON (B)(6) 2011. THE HP WAS TREATED WITH ANCEF, BUT REPORTED BURNING PAIN WHEN INSTILLING THE SOLUTION CONTAINING ANCEF. THE PATIENT'S LAST DOSE OF IP (B)(6) IS SCHEDULED FOR (B)(6) 2011. THE PATIENT IS STILL CURRENTLY EXPERIENCING CRAMPING DURING THERAPY. THE NURSE STATED SHE IS NOT SURE IF THE PATIENT IS SENSITIVE TO THE PH OR POSSIBLY THE (B)(6). THERE WAS NO EXIT SITE OR TUNNEL INFECTION. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. PATIENT OUTCOME WAS UNKNOWN AT THIS TIME. A CULTURE AND ANALYSIS WILL BE REPEATED IN TWO WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention HOMECHOICE DEVICE