BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3771106 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13230
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ALTHOUGH THE HOME PATIENT STATED HE DID NOT CHECK THE PATIENT LINE FOR A COMPLETE PRIME BEFORE CONNECTING, INSUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE THE CAUSE OF THE ALARM. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) DEVICE DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HP WAS CONNECTED. THE HP ALSO STATED THAT THEY SAW ¿AIR POCKETS¿ IN THE PATIENT LINE. DURING TROUBLESHOOTING, THE HP STATED THAT THEY DID NOT CHECK THE PATIENT LINE FOR A COMPLETE PRIME BEFORE CONNECTING. PATIENT EXTENSION LINES WERE USED AND WERE CONNECTED PRIOR TO PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE IMPORTANCE OF CHECKING THE PATIENT LINE TO MAKE SURE IT IS FULLY PRIMED. THE TSR THEN ASSISTED THE HP IN ENDING THERAPY AND REMOVING THE CASSETTE. THE HP WAS TO COMPLETE THERAPY USING NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249972 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE