BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2149090 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06557
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    July 12, 2008
    Report Date
    July 12, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING SUBMITTED AS PART OF RETROSPECTIVE SUMMARY REPORT # (B)(4). THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED ON THIS MDR ARE 101 - "FKX REPORTABLE DEATH AND SERIOUS INJURIES". THESE REPORTS ARE BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING - LETTER (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE DISPLAY OF THE HOME PATIENT'S HOMECHOICE MACHINE DURING THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. PER THE INITIAL REPORT, THE PATIENT LINE WAS NOT CONNECTED TO THE TRANSFER SET BEFORE PRESSING GO TO BEGIN INITIAL DRAIN/THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. ADDITIONAL INFORMATION WAS OBTAINED FROM THE HOME PATIENT'S NURSE ON (B)(6) 2008 REGARDING A REPORT OF PERITONITIS AND CLOUDY EFFLUENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008. THE NURSE BELIEVES THE CAUSE OF THE PERITONITIS WAS DUE TO CONTAMINATION BASED ON THE CULTURE RESULTS. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSAGE UNKNOWN). THE NURSE ALSO STATED THE PATIENT WAS NEW TO THE AREA AND HAD UNDERGONE TRAINING WITH THE PREVIOUS CLINIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2008, BUT WAS READMITTED TO THE HOSPITAL WITH A (B)(6) INFECTION ON (B)(6) 2008. PER THE NURSE, THE PATIENT IS STILL IN THE HOSPITAL RECOVERING FROM THE (B)(6) INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R LO/CAL 6L DIANEAL (B)(4) | LO/CAL 6L DIANEAL (B)(4) | LO/CAL 6L DIANEAL (B)(4) | LO/CAL 6L DIANEAL (B)(4)| LO/CAL 6L DIANEAL (B)(4)| LO/CAL 6L DIANEAL (B)(4)