BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2081797 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05623
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CHECK PATIENT LINE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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

    THE NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING FILL 1. THE RN STATED THE PATIENT LINE WAS FULL OF AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO END TREATMENT TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE RN WHO STATED THERAPY RESUMED WITH NEW SUPPLIES. THE RN STATED THE HP WAS CURRENTLY IN THE HOSPITAL. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THE HP WAS NOT IN THE HOSPITAL DUE TO THE REPORTED INCIDENT NOR DUE TO PD THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    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 81 YR HOMECHOICE