BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212378 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10731
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 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). PER THE CUSTOMER, 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 WAS NOT CONFIRMED; THE ROOT CAUSE COULD NOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 DWELL 3 OF 5. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. 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. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, THEY DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT THEY WERE DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 67 YR HOMECHOICE