BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2921421 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01345
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED HIGH DRAIN 103 ALARM WAS CONFIRMED FOR THE CRITERIA OF IIPV. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF HIGH DRAIN 103 (IIPV-ADULT). THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 103 ALARM DURING THE START OF THERAPY ON THE HOMECHOICE MACHINE(HC). THE HOME PATIENT(HP) STATED THEY HAD CHEST PAINS LAST NIGHT AND THEY STOPPED THERAPY IN ORDER TO GO TO THE EMERGENCY ROOM. THE HP STATED THE EMERGENCY ROOM WAS UNABLE TO DETERMINE THE CAUSE OF THE CHEST PAINS. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HP TO CLEAR THE ALARM AND CONTINUE THERAPY PER THEIR REQUEST. ON 04 JAN 2013 PRODUCT SURVEILLANCE CONTACTED THE FACILITY AND SPOKE WITH PERITONEAL DIALYSIS (PD) NURSE. THE NURSE REPORTED THAT THE PATIENT'S CHEST PAIN WAS NOT RELATED TO THE HOMECHOICE DEVICE OR PD THERAPY. THE PATIENT'S CHEST PAIN HAS RESOLVED. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME. ON (B)(6) 2013 PRODUCT SURVEILLANCE CONTACTED THE FACILITY AND SPOKE WITH PD NURSE. THE NURSE REPORTED THAT THE PATIENT'S CHEST PAIN WAS NOT RELATED TO THE HOMECHOICE DEVICE OR PD THERAPY. THE PATIENT'S CHEST PAIN HAS RESOLVED. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27512 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE