BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192843 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10319
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 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). 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.

    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 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) DID NOT DISCONNECT, THERE WERE NO UNUSED LINES OPEN, NO LEAKS, AND THEY CYCLED THE POWER. SYSTEM ERROR 2367 OCCURRED. THE TSR ASSISTED THE HP TO RETRIEVE THE CASSETTE. THE TSR ADVISED TO LET THE REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO INJURY OR MEDICAL INTERVENTION. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED; HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. PER HP, THEY DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT THEY HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 61 YR HOMECHOICE