BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2083610 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05717
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR CHECK SUPPLY LINE ALARM WAS NOT CONFIRMED. THE CAUSE OF THE USE ERROR WAS SWITCHING BAGS WHILE CONNECTED. 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 FOR CHECK LINES AND BAGS ALARMS IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY WHILE REFILLING THE HEATER DURING FILL 6 OF 6, THE NURSE REPORTED THAT THE PERSON THAT PERFORMED THE SETUP THE NIGHT BEFORE DID NOT PUT ON ENOUGH SOLUTION, SO SHE TOOK THE EMPTY HEATER BAG OFF AND REPLACED IT WITH ANOTHER SOLUTION BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO HER THAT WAS NOT THE PROPER PROCEDURE AND THAT COULD CONTAMINATE THE SET. THE NURSE STATED THAT SHE USED STERILE PROCEDURE AND CLAMPED OFF THE LINE, AND WANTED TSR TO ASSIST HER IN CLEARING THE ALARM. THE TSR ASSISTED IN BYPASSING REFILLING THE HEATER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. DURING A FOLLOW UP WITH THE FLOOR NURSE AT THE MEDICAL CENTER ON (B)(6) 2011 REGARDING THE USE ERROR AND THE ALARM, THE FLOOR NURSE THAT THEY WOULD NOT BE ABLE TO FIND THE PATIENT IN QUESTION AND WOULD NOT BE ABLE TO PROVIDE ANY FURTHER INFORMATION ABOUT THE PATIENT OR THE PATIENT'S CONDITION.

    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 HOMECHOICE