BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2983640 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04977
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 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). A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS OPERATIONAL AND WAS NOT RETURNED FOR EVALUATION. THE PRODUCT ANALYSIS LAB (PAL) CONFIRMED THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) BASED ON REPORTED INFORMATION. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS DETERMINED TO BE: INSUFFICIENT DRAIN, FALSE EMPTY DETECT AND USE ERROR, INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED TOO LOW. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE STATES IN THE WARNINGS: "SETTING THE I-DRAIN ALARM VOLUME TOO LOW OR OFF CAN RESULT IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. SEE TABLE 9-1 ON PAGE 9-10 FOR THE RECOMMENDED STARTING POINTS WHEN DETERMINING YOUR OPTIMAL I-DRAIN ALARM VOLUME." AND TABLE 9-1 ON PAGE 9-10 GIVES THE RECOMMENDED STARTING POINT FOR I-DRAIN ALARM SETTING AS 70% OF THE LAST FILL VOLUME. 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 101/CALL PDRN ALARM ON A HOMECHOICE (HC) DEVICE DURING DRAIN 1 OF 4. THE PATIENT WAS CONNECTED. THE HP DID FILL 1 OF 3 LITERS AND STATED SHE FELT FULL BUT CONTINUED WITH THERAPY. THE INITIAL DRAIN ALARM WAS SET TO 0ML. THE HP UNDERSTOOD THE REASON FOR THE ALARM AND WILL CALL THE REGISTERED NURSE (RN) BACK TO ADVISE. THE HP DOES NOT WANT A SWAP. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) SUGGESTED THAT SHE HAVE THE RN PUT IN A VALUE FOR INITIAL DRAIN ALARM (IDA), AND ALSO PROVIDED INSTRUCTIONS ON HOW TO DO A MANUAL DRAIN. 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
    87504 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR