BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2904326 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00655
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 NUMBER H12I08034. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). DIANEAL PD4 AMBUFLEX WAS REMOVED AS A CONCOMITANT PRODUCT AND DIANEAL PD4 ULTRABAG WAS ADDED AS A CONCOMITANT PRODUCT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PD. DIANEAL THERAPY WAS ONGOING. THE PATIENT HAD EXTRANEAL IN HIS PRESCRIPTION, HE HADN'T HAD TO USE IT LATELY, BUT THE EXACT ACTION TAKEN WAS NOT REPORTED. THE NURSE CONFIRMED THE EVENT OF PERITONITIS AND THE HOSPITAL ADMISSION DATE AS PREVIOUSLY REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS INITIALLY TREATED WITH VANCOMYCIN IP AND WHEN THE CAUSATIVE ORGANISM WAS IDENTIFIED, THE PATIENT WAS SWITCHED TO CEFAZOLIN IP. THE CAUSE OF PERITONITIS WAS UNCERTAIN. THE NURSE STATED THAT THE PATIENT USED GOOD PD TECHNIQUE. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT. 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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS (ONSET DATE AND CAUSE NOT REPORTED) AND ALSO FOR AN UNSPECIFIED TEST. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12413 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization EXTRANEAL VIAFLEX| DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX