BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192037 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10281
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SYSTEM ERROR 2267 WAS CONFIRMED, AND THE CAUSE WAS DETERMINED TO BE USE ERROR. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. THE CUSTOMER ELECTED TO DISCARD THE SAMPLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2267 ALARM THAT OCCURRED DURING DWELL 3 OF 4 OF THERAPY ON THE HOMECHOICE (HC) UNIT. THE HP STATED HE CYCLED POWER TO CLEAR THE ALARM PRIOR TO CALLING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED POSSIBLE CAUSES. THE HP CONFIRMED TO COMPLETE THERAPY WITH MANUAL EXCHANGE AND TO NOTIFY THE NURSE OF THE EVENT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE ALARM. THE HP STATED THAT THE ISSUE WAS RESOLVED. THE HP VERIFIED THAT THERE WERE NO DISCONNECTIONS OR DEFECTS NOTED WITH THE SUPPLIES. THE HP STATED HE DID NOT TIGHTEN THE LINE TO THE HEATER BAG ENOUGH AND BELIEVED THAT CAUSED THE AIR TO GET INTO THE LINE. THE HP STATED HE IS CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 52 YR HOMECHOICE PRO