BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171821 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09304
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. THEREFORE THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 WAS CONFIRMED, AND THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR- THE PATIENT DISCONNECTED FROM THE SET. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2240 ALARM WHICH OCCURRED DURING DRAIN 4 OF 4 ON THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT DISCONNECTED TO GO TO THE BATHROOM AND RECONNECTED AFTER THE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) TO CYCLE POWER TO CLEAR THE ALARM AND TO GET THE SET OUT. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO CONFIRMED THIS WAS AN ISOLATED EVENT. THE HP STATED SHE IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED

    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 53 YR HOMECHOICE PRO