BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171835 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09303
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON THE UNUSED SUPPLY LINE. LABELING REVIEW FINDS THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 ON THE HOMECHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND REVIEWED THE POSSIBLE CAUSES. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN). THE RN STATED THE HP WAS CONNECTED AT THE TIME OF ALARM AND THAT ONE OF THE UNUSED LINES WERE NOT CLAMPED OFF. THE RN REVIEWED THE PROPER PROCEDURE WITH THE HP, HAD THE HP PERFORM A MANUAL EXCHANGE, AND DISPOSE OF THE SUPPLIES. THE RN STATED THERE WAS NO INJURY OR MEDICAL INTERVENTION AND THE HP HAS BEEN PERFORMING PERITONEAL DIALYSIS (PD) THERAPY FINE NOW. NO FURTHER INFORMATION IS AVAILABLE.

    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 18 YR HOMECHOICE