BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2210318 · Received August 12, 2011

    Report

    Report Number
    1423500-2011-10666
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012, BAXTER PRODUCT SURVEILLANCE RECEIVED A REPLY FROM A REQUEST FOR FURTHER INFORMATION FROM THE RISK MANAGER (RM) AT THE MEDICAL FACILITY. THE RM STATED THEY HAVE NO RECORD OF THE REPORTED PATIENT. NO FURTHER CLINICAL INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED AND EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). THE REPORTED CONDITION OF PATIENT SYMPTOM (RESPIRATORY ARREST) WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE OF THE REPORTED CONDITION IS UNDETERMINED. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF PATIENT SYMPTOM (RESPIRATORY ARREST). A TWO (2) YEAR REVIEW OF THE SERVICE HISTORY REVEALED NO PRIOR SERVICE DATA AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE PASSED ALL TESTS AND CALIBRATIONS PER HOMECHOICE SERVICE FINAL TEST AND CALIBRATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN AT THIS TIME IF THE DEVICE IS AVAILABLE FOR EVALUATION. WHEN THE DEVICE OR IF ADDITIONAL INFORMATION BECOME AVAILABLE, AN EVALUATION WILL BE CONDUCTED AND/OR A FOLLOW-UP REPORT SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER FOR ASSISTANCE WITH THE HOME CHOICE (HC) NEEDING TO KNOW HOW MUCH FLUID WAS DRAINED DURING A MANUAL DRAIN PERFORMED DURING DWELL 3 OF 8. THE HOME PATIENT (HP) HAD BEEN DISCONNECTED AND DRAINED DUE TO AN EVENT OF RESPIRATORY ARREST WHILE ON THE HC. THE HC CYCLE WAS REVIEWED WITH THE CALLER. ULTRAFILTRATION (UF) FOR CYCLE 3 EQUALED 7ML. THE CALLER STATED THE RESPIRATORY ARREST WAS NOT RELATED TO THE HC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other