BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3900694 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20746
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) SAW AIR IN THE PATIENT LINE OF THE AUTOMATED PERITONEAL DIALYSIS (APD) SET WITH CASSETTE WHICH OCCURRED DURING THERAPY ON THE HOMECHOICE (HC) DEVICE DURING INITIAL DRAIN. THE HP WAS CONNECTED AT THE TIME OF THE EVENT. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THERE WAS A BIT OF AIR THAT WENT INTO THE CASSETTE AND THEY NEVER SAW THE AIR COMING OUT. THE HC DID NOT STOP AND IT PROCEEDED TO FILL 1. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE TSR ADVISED AND ASSISTED THE HP IN ENDING THE THERAPY. THE TSR ALSO ADVISED THE HP TO START OVER USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377713 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE