BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1839447 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03549
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS FOR THE CASSETTE (H10F14014, H10E14073) , WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN AN APPROXIMATELY (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED "GI (GASTROINTESTINAL) PROBLEMS." ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED DIAGNOSIS. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE NURSE STATED THAT SHE WAS NOT SURE WHAT CAUSED THE PERITONITIS, STATING THAT THE "PATIENT'S CATHETER WAS NOT WORKING WELL AND PATIENT'S CATHETER WAS SHIFTED." ON AN UNREPORTED DATE IN (B)(6)2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT FOR THE "GI PROBLEMS." IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE "GI PROBLEMS" RESOLVED.

    Description of Event or Problem · 1

    ON (B)(6)2010, IT WAS FOUND THAT THIS LEAD HAD DISLODGED. SURGICAL INTERVENTION TO REPOSITION THE LEAD WAS PERFORMED. THIS DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIANEAL PD4 ULTRABAG