BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2003095 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02533
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 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). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2367 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DRAIN 4 OF 4. THE HP (HOME PATIENT) HAD ALREADY CYCLED POWER AND HP GOT SE 2240. THE HP STATED THAT HE DID NOT DISCONNECT. THERE WERE NO LEAKS AND NO BAGS WERE DISCONNECTED. THE HP WILL COMPLETE THERAPY WITH MANUAL SUPPLIES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DOCUMENTED THAT THE ALARM WAS CLEARED. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT WAS CONTACTED ON (B)(6) 2011. THE HOME PATIENT STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THE HP HAS DISCARDED THE SUPPLIES AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE ARE NO COMPANION SAMPLES AVAILABLE. THE HOME PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE HP IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. ACCORDING TO THE HP THIS WAS AN ISOLATE INCIDENT.

    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 HOMECHOICE