BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2191448 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10270
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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 A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO USE ERROR. 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.

    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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 ALARM DURING THE INITIAL DRAIN ON THE HOMECHOICE MACHINE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER(CG) TO CYCLE POWER. THE TSR ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THE CG WAS CONTACTED ON (B)(6) 2011. THE CG CLARIFIED THAT THE CAUSE OF THE ALARM WAS BECAUSE THEY HAD ACCIDENTALLY LEFT THE CLAMP OPEN ON THE THIRD LINE. THE CG STATED THIS WAS AN ISOLATED EVENT. THE CG STATED THAT THE HOME PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE CG ALSO STATED THE HOME PATIENT 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 77 YR HOMECHOICE