BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171768 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09295
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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). DURING A FOLLOW UP WITH THE HOME PATIENT (HP)'S WIFE REGARDING THE USE ERROR, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THEY HAVE LEARNED SINCE THE INITIAL CALL THAT THEY ARE SUPPOSED TO START OVER USING ALL NEW SUPPLIES, AND NOT JUST ONE OF THE SUPPLIES. PER THE HP'S WIFE, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE WIFE STATED THAT THE HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT FOR A REPORT OF AN USER ERROR WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK FINAL LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE CAREGIVER (CG) REVEALED THAT SHE HAD SET UP WITH A NEW CASSETTE, BUT DID NOT CHANGE OUT THE BAGS AS WELL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HOME PATIENT (HP) WOULD NEED TO START OVER WITH ALL NEW SUPPLIES BECAUSE THE SETUP WAS COMPROMISED AND ADVISED THE CG TO CONTACT THE NURSE. THERE WAS PATIENT INVOLVEMENT BUT 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SOLUTION BAGS