BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3021331 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07267
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED FOR DEVICE EVALUATION FOR THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER?S GUIDE SECTION 12 "PROGRAMMING A PRESCRIPTION" IN 12.3.3 ON PAGE 12-6 GIVES THE WARNING THAT "IF YOU SET THE MINIMUM DRAIN VOLUME% TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD CAUSE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN 104/CALL PD NURSE ALARM ON A HOMECHOICE (HC) DEVICE DURING POWER UP FOR TONIGHT'S THERAPY, PATIENT NOT CONNECTED. (HIGH DRAIN ALARM INDICATES AN IIPV SITUATION. THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE.) THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND CLEARED IT. THE HOME PATIENT (HP) STATED HE IS USING 2.5% AND 4.25% STRENGTH SOLUTION. THE HP STATED THAT HE FELT FULL AND HAS HAD DIFFICULTY BREATHING DURING PREVIOUS THERAPIES, BUT DID NOT NOTIFY THE NURSE. THE HP STATED HE HAS NO SYMPTOMS AT THIS TIME. THE TSR INSTRUCTED THE HP TO FOLLOW UP WITH THE NURSE TONIGHT REGARDING THE HIGH DRAIN ALARM AND DIFFICULTY BREATHING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE HP HAS THE PROCARD TO PROGRAM THE NEW HC. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123554 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE