BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080357 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05601
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE BATCH REVIEW WAS PERFORMED ON A POTENTIALLY ASSOCIATED LOT (H11C12485) WITH NO ISSUES NOTED. 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 HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND THAT THE HP NEEDED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS MADE VIA PHONE CALL. THE HP STATED THAT HE WAS NOT SURE WHAT MAY HAVE CAUSED THE ALARM, BUT BELIEVED IT COULD HAVE EITHER BEEN THE CASSETTE OR THE FRANGIBLE OF THE BAG. THE HP WAS USING THE PATIENT EXTENSION LINES, BUT HAD CONNECTED THEM PRIOR TO PRIME. THE HP HAD NOT NOTIFIED THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ABOUT THE ALARM. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    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 H11C12485

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HOMECHOICE