BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1971170 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01054
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 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 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 RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240. THE HOME PATIENT (HP) STATED SHE HAD DISCONNECTED AFTER THE ALARM OCCURRED. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM AND REMOVE THE CASSETTE. THE TSR ADVISED THE HP TO CONTACT THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP CALL, THE HOME PATIENT (HP) STATED THAT SHE WAS CONNECTED AT THE TIME OF THE ALARM AND DID NOT DISCONNECT UNTIL AFTER SHE RECEIVED THE ALARM. THE HP STATED SHE DID NOT START OVER WITH NEW SUPPLIES. THE HP STATED SHE WAS ABLE TO RESUME THERAPY THE FOLLOWING NIGHT. THE HP DID NOT CONTACT HER PERITONEAL DIALYSIS NURSE. THE HP WAS ADVISED TO LET HER NURSE KNOW OF THE ALARM. THE HP STATED SHE HAS FELT FINE WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HOMECHOICE CYCLER