BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1953107 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00268
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    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 COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE PATIENT'S THERAPY, IN DAY DRAIN 1 OF 1. THE PATIENT EXPLAINED HE WAS RUNNING LATE AND THOUGHT HE HAD CONNECTED BEFORE PRESSING "GO" TO START, BUT WAS NOT SURE. GTS HAD THE PATIENT CLOSE ALL THE CLAMPS TO CYCLE POWER TWICE, CLEARING THE ERROR. THE PATIENT WAS UNABLE TO SETUP THE HC ON HIS OWN, AND ELECTED TO HAVE THE CAREGIVER SETUP THE HC LATER. THE PATIENT STATED THEY WOULD CALL BAXTER FOR BYPASS ASSISTANCE FOR THE DAY EXCHANGE. GTS ADVISED THE PATIENT TO LET THEIR DIALYSIS NURSE KNOW OF THE ERROR. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THAT EVERYTHING WAS FINE. THE PATIENT DID NOT RECALL WHAT HAPPENED INITIALLY, BUT STATED HE WAS ABLE TO RESUME THERAPY AFTER STARTING OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE PRO APD CYCLER (B)(4) (REFURBISHED)