BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1994219 · Received February 17, 2011

    Report

    Report Number
    1423500-2011-02071
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 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). 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 SUPPLY BAG CAME DISCONNECTED FROM THE SUPPLY LINE. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE 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 RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING FILL 1. GTS HAD THE HOME PATIENT (HP) CYCLE POWER. THE HP STATED THAT THE HEATER BAG HAD BECOME DISCONNECTED FROM THE SETUP BEFORE THE SYSTEM ERROR 2240 OCCURRED. GTS EXPLAINED THE ALARMS TO THE HP AND THAT SHE WOULD NEED TO START THE SETUP WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE HOME PATIENT (HP) SAID SHE GOT THE ALARM ABOUT AN HOUR INTO THERAPY, AND DID NOT KNOW HOW THE DISCONNECTION OCCURRED. SHE SAID THAT SHE DOES NOT THINK THAT THE NEW LUER LOCK CONNECTIONS ARE AS SECURE AS THE SPIKE SUPPLIES, HOWEVER, DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. SHE DID NOT NOTIFY HER NURSE, AND THE WRITER ADVISED TO CONTACT THE NURSE ANY TIME THERE IS AIR FOUND IN THE LINE. THE HP SAID SHE HAD RESUMED THERAPY SUCCESSFULLY AND HAD NOT HAD ANY PROBLEMS SINCE. 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 H10K08074

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE CYCLER