BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1894575 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05551
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    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). THE ISSUE WAS RESOLVED OVER THE PHONE. THIS WAS AN INCIDENT INVOLVING A USER ERROR DURING THERAPY AND THERE WAS NO ALLEGATION AGAINST THE BAXTER PRODUCT; THEREFORE THE SAMPLE WILL NOT BE REQUESTED FOR EVALUATION. 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 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 CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. THE PATIENT PRESSED GO AND STARTED THE INITIAL DRAIN. AFTER REALIZING THAT THEY WERE NOT CONNECTED, THEY CONNECTED TO THE HOMECHOICE AND RECEIVED THE 2240 ALARM. 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 POTENTIAL 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE HOME PATIENT (HP) PRESSED GO AND STARTED THE INITIAL DRAIN. AFTER REALIZING THAT HE WAS NOT CONNECTED, HP THEN CONNECTED TO THE HC MACHINE AND RECEIVED THE 2240 ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP AND ASSISTED TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START OVER AGAIN USING NEW SUPPLIES. DURING A FOLLOW UP WITH THE NURSE REGARDING THE ALARM, IT WAS REVEALED THAT THE SHE HAD ADVISED THE HP OF THE APPROPRIATE PROCEDURE AND EXPLAINED THE IMPORTANCE OF FOLLOWING PROCEDURE. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUES AS FAR AS SHE KNOWS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 55 YR