BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2823080 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04320
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    June 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H12C24026 AND H12C11023. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER TECHNICAL SERVICES (BTS), THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WENT TO THE EMERGENCY ROOM (ER), BUT WAS NOT HOSPITALIZED OVERNIGHT. THE PATIENT WAS DISCHARGED FROM THE ER ON THE SAME DAY. THE NURSE CONFIRMED THAT THE PATIENT DID NOT HAVE (B)(6), AN EXIT SITE INFECTION, TUNNEL INFECTION, OR DISCOLORATION OF PD EFFLUENT. THE NURSE THOUGHT THAT THE PATIENT MIGHT HAVE PICKED UP THE INFECTION WHEN THE PD CATHETER WAS INITIALLY PLACED IN (B)(6) 2012, BUT COULD NOT CONFIRM. TREATMENT WAS NOT REPORTED. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    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 43 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX