BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071527 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05116
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 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). THE REPORT FOR SYSTEM ERROR 2267 (FLUID AND AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 2267 ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 2 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE POWER ON THE HC AND HAD THE HP DISCONNECT AND REMOVE CASSETTE TO DISCARD SUPPLIES. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR ALARM AND ADVISED TO NOTIFY THE NURSE. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE WAS AWARE OF THE ALARM AND STATED THAT THE HP WAS DOING FINE. THE HP DID NOT MENTION ANYTHING ABNORMAL ABOUT THE SUPPLIES AT USE. PER THE NURSE, THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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 48 YR HOMECHOICE