BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2093445 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06155
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 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). 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). DURING A FOLLOW UP WITH A CLINIC STAFF MEMBER (CSM) REGARDING THE ALARM, IT WAS REVEALED THAT THE HP WAS SEEN IN THE CLINIC ON (B)(6) 2011, AND PER THE NURSE NOTES, THE HP WAS RETRAINED ON THERAPY. THE HP IS CONTINUING THERAPY. 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; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. 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 (B)(4) REGARDING A SYSTEM ERROR ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL CYCLE. THE HOME PATIENT (HP) HAD THE CLAMPS OPEN ON THE UNUSED LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO CLEAR THE ALARM. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THE HP WOULD COMPLETE THERAPY. 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 55 YR HOMECHOICE