BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2023767 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03389
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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). THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP WITH THE HOME PATIENT (HP)'S CAREGIVER (CG) REGARDING THE REPORTED EVENT, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED BY STARTING OVER USING ALL NEW SUPPLIES. PER CG, THEY ARE AWARE OF THE PROPER PROCEDURES. THE CG CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE CG STATED THAT THE HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE CAREGIVER (CG) STATED SHE WAS TRYING TO HOOK THE PATIENT UP TO THE SUPPLY LINE AT FIRST. SHE THEN REALIZED WHAT SHE WAS DOING, BUT FIRST PRESSED GO ANYWAY AND THEN HOOKED THE PATIENT UP TO THE PATIENT LINE. THE HC THEN ALARMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THEN EXPLAINED PROPER SET-UP PROCEDURES AND ASSISTED THE CG TO CYCLE POWER OFF/ON TO CLEAR ALARM. THE TSR INSTRUCTED THE CG TO START OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 62 YR HOMECHOICE