BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171648 · Received July 21, 2011

    Report

    Report Number
    1423500-2011-09285
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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 NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE FILED UPON IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4). BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING AN UNKNOWN THERAPY STEP. THE HOME PATIENT (HP) WAS CONNECTED. THE TSR EXPLAINED THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ON (B)(6) 2011 REGARDING THE HOME PATIENT (HP) HAVING A SYSTEM ERROR (SE) 2240. THE PD RN WAS AWARE OF THE PROBLEM. THE PD RN DID NOT KNOW WHAT CAUSED THE ALARM. THE PD RN DID NOT HAVE THE LOT NUMBER OR SAMPLE INFORMATION. THE PD RN STATED THAT THE HP JUST ENDED THERAPY THAT NIGHT SINCE THEY WERE AT THE END OF THE THERAPY. PER THE PD RN, THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. 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 68 YR HOMECHOICE