BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962047 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00694
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR WAS SUBMITTED ON 01/14/2011; HOWEVER, DUE TO A FAILED ACK3, THIS MDR IS BEING RESUBMITTED ON 01/17/2011. 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 GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM, WHICH APPEARED ON THE HOME CHOICE (HC) DURING THE INITIAL DRAIN. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HAD THE CAREGIVER (CG) CYCLE POWER TO CLEAR THE ALARM. THE TSR ADVISED THE CG TO START OVER WITH NEW SUPPLIES AND CALL THE NURSE IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE HOME PATIENT'S (HP) NURSE, SHE STATED THAT THE PATIENT DID NOT REPORT ANY ISSUES WITH THERAPY, THE PATIENT CONTINUED THERAPY, NO ADVERSE EVENT WAS REPORTED, THE PATIENT WAS FINE AND THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION AS A RESULT OF THIS INCIDENT.

    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 57 YR HOMECHOICE CYCLER