BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120867 · Received June 11, 2011

    Report

    Report Number
    1423500-2011-07474
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(4) 2011 REGARDING THE OVERPRIME ISSUE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT THE HOME PATIENT (HP) HAS BEEN RE-TRAINED. PER NURSE, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE 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. ENGINEER/QUALITY REVIEW: THIS COMPLAINT WAS NOT CONFIRMED. THE CAUSE WAS THE PATIENT STACKING SOLUTION BAGS ON TOP OF EACH OTHER DURING THERAPY; A 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE PATIENT LINE WAS OVERPRIMING DURING THE PRIMING STEP ON THE HOMECHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HOME PATIENT (HP)'S NURSE IF THEY HAD A BAG ON TOP OF THE HEATER BAG, AND THE NURSE STATED YES. THE TSR ADVISED THE NURSE TO PLACE THE EXTRA BAG TO THE SIDE. THERE WAS PATIENT INVOLVEMENT BUT 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE