BEUDAMED
    FDA Adverse Event Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243301 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12058
    Date Received
    September 12, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 27, 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 SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; 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 A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET ) DURING DWELL 3 OF 5 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED THAT HE WAS CONNECTED TO THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE THE POWER CYCLE TWICE ON THE HC AND THE HC PROCEEDED TO PRESS GO TO START. THE HP STATED THAT HE WOULD PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) FOR THE THERAPY. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) WAS IN THE CLINIC THE DAY BEFORE AND DID NOT MENTION ANY PROBLEMS OR ALARMS. PER THE PD RN, THE HP WAS DOING FINE WITH THERAPY ON THE CYCLER. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 63 YR HOMECHOICE