BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2041274 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04141
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 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). THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ON THE HOMECHOICE DURING DRAIN. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED PRIOR TO THE ALARM. THERE WERE NO PROBLEMS NOTED WITH THE SUPPLIES AND NO LOOSE CONNECTIONS WERE SEEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ALARM TO THE HP AND ADVISED TO CLOSE ALL CLAMPS AND DISCARD SUPPLIES. THE HP WILL FINISH WITH MANUAL SUPPLIES. THE CAUSE OF THE ALARM WAS UNDETERMINED. FOLLOW-UP WITH THE CAREGIVER ON (B)(4) 2011 CONCERNING THE ALARM REVEALED THEY WERE ABLE TO FINISH THERAPY WITH MANUAL SUPPLIES AND HAVE HAD NO FURTHER PROBLEMS SINCE THAT DAY. THERAPY HAS BEEN GOING SMOOTHLY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 HOMECHOICE