BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2213879 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10801
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE LOT NUMBER IS KNOWN, THEREFORE A BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS NOT CONFIRMED THROUGH AN EVALUATION OF A COMPANION SAMPLE. HOWEVER, BASED ON THE HOME PATIENT (HP) STATING THAT SOMETIMES IT HELPS TO CHANGE ONLY THE BAG ON THE HEATER PLATE, BUT SOMETIMES IT IS NECESSARY TO COMPLETELY CHANGE BOTH - THE CASSETTE AS WELL THE BAG, THE CAUSE WAS DETERMINED TO BE USE ERROR. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CALLED BAXTER TO REPORT AN ISSUE OF CHECK HEATER LINE WHICH OCCURED IN THE 2ND PHASE AFTER THE HP CONNECTED TO THE HOME CHOICE (HC) AND WAS UNABLE TO START THE 1ST FILLING CYCLE. THE HP REPORTED THEY SOMETIMES CHANGE ONLY THE BAG ON THE HEATER PLATE, BUT SOMETIMES IS NECESSARY TO COMPLETELY CHANGE BOTH - THE CASSETTE AS WELL THE BAG TO RESOLVE THE ALARM. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 - SINGAPORE S10K10096

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE