BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2220724 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11103
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF PERITONITIS WAS NOT CONFIRMED. A BATCH REVIEW WAS PERFORMED FOR H11D20015 AND AN EXCEPTION WAS NOTED BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H11C16015 AND H11B19094 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THERE WAS NO REPORT OF ANY TYPE OF USE ERROR THAT WOULD HAVE LED TO THIS ISSUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED AND AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT 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 71 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE