BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1993980 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02052
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE HOME PATIENT (HP) TO TROUBLESHOOT. THE TSR EXPLAINED TO REPORT THE ALARMS TO THE PERITONEAL DIALYSIS NURSE THE NEXT MORNING. THE HP WOULD COMPLETE THERAPY MANUALLY FOR THE NIGHT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE HP STATED THAT HE COULD NOT RESUME WITH THE THERAPY THAT NIGHT AND HAD TO SKIP A NIGHT OF THERAPY. HE STATED THAT HE RESUMED THE NEXT DAY WITH ALL NEW SUPPLIES AND CONTACTED HIS NURSE TO LET THEM KNOW WHAT HAPPENED. HE STATED HE DIDN'T NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT THE TIME AND HASN'T HAD ANY PROBLEMS SINCE. HE STATED HIS THERAPY IS GOING EXTREMELY WELL AND REPORTED NO INJURY OR MEDICAL INTERVENTION.

    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 67 YR HOMECHOICE CYCLER