BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141228 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08389
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 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). ON (B)(4) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE ALARM. THE RN WAS MADE AWARE OF THE ALARM. THE RN STATED THEY WERE NOT AWARE OF THE EVENT. THE RN STATED THE HOME PATIENT (HP) HAS HAD NO INJURY OR MEDICAL INTERVENTION FROM THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS UNAVAILABLE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; THE ROOT CAUSE WAS UNDETERMINED. 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 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 4. THE HOME PATIENT (HP) STATED THAT THE HC DISPLAYED SE 2240 IN DWELL 4. THE HP STATED THE HC THEN DISPLAYED SE 2367. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP THE POWER CYCLE THE HC. THE HC PROCEEDED TO PRESS GO TO START. THE POWER CYCLING THE HC CLEARED SE 2240 AND SE 2367. THE HP STATED THAT THEY WOULD PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) FOR THE REST OF THEIR THERAPY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY PRODUCTCODE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR HOMECHOICE