BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1943223 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07464
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 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 BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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).

    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 (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT HAD APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN. THE NURSE REPORTED THAT THE HOME PATIENT (HP) TRIED TO CLEAR THE SE 2240 ALARM BUT HE WAS UNABLE TO. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECOMMENDED THAT THE HP CONTACT BAXTER AT THE TIME OF THE ALARMS FOR TROUBLESHOOTING ASSISTANCE. THE TSR EXPLAINED THE ALARM TO THE NURSE AND THE HP. BASED ON THE SE 2240 CALLSCRIPT, PATIENT EXTENSION LINES WERE USED; HOWEVER, THE EXTENSION LINES WERE NOT CONNECTED PRIOR TO PRIMING. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE REGARDING THE ALARM, IT WAS REVEALED THAT THE HP HAD RESUMED THERAPY SINCE THAT TIME. THE NURSE STATED THAT THERE WERE NO ADVERSE EVENTS FROM THIS ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HC CYCLER