BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022654 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03321
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 4 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 UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10A06110, H10B04030), WITH NO DEFECTS NOTED. AN EXCEPTION WAS NOTED FOR LOT NUMBER (H10B10037) FOR LOOSE PARTICULATE MATTER ASSOCIATED WITH THE PULL RING CAP COMPONENT. THERE IS NO EVIDENCE TO SUPPORT ASSOCIATION TO THE REPORTED PROBLEM. THE AFFECTED PRODUCT WAS 100% INSPECTED. AFTER CORRECTIVE ACTIONS WERE IMPLEMENTED, QUALITY INSPECTIONS WERE ACCEPTABLE WITH ALL PRODUCT RELEASE REQUIREMENTS ACCEPTABLE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER REPORTED THE FOLLOWING. IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. UPON A FOLLOW UP CALL WITH THE PATIENT'S NURSE, THE NURSE STATED THAT THERE WAS NO RECORD OF DIAGNOSIS OF PERITONITIS OR PD EFFLUENT CULTURE PERFORMED IN (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED SYMPTOMS OF PERITONITIS. THE PATIENT WAS TREATED WITH IP VANCOMYCIN (DOSE, FREQUENCY UNREPORTED), AND WAS NOT HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011, THE PATIENT HAD A CLOUDY BAG. THIS EVENT WAS CONSIDERED A RECURRENT/ RELAPSED PERITONITIS, WHICH WAS TREATED WITH IP VANCOMYCIN (DOSE, FREQUENCY UNREPORTED). ON (B)(6) 2011, THE LAST DOSE OF VANCOMYCIN WAS GIVEN. ON (B)(6) 2011, PD THERAPY WAS WITHDRAWN AND THE PD CATHETER WAS REMOVED. ON (B)(6) 2011, THE PATIENT STARTED TEMPORARY HEMODIALYSIS (HD). THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR BACILLUS WAS UNRELATED TO DIANEAL THERAPY.

    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 67 YR Required Intervention DIANEAL PD4 AMBUFLEX