BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3002944 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06078
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT DID NOT MEET CRITERIA FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV) AS IT OCCURRED DURING THE INITIAL DRAIN. THE DRAIN VOLUME REPORTED WAS CONFIRMED DURING EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. THE DEVICE WAS SENT FOR SERVICING.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) ON A HOMECHOICE (HC) DEVICE. THE REGISTERED NURSE (RN) STATED THAT SHE WAS GOING THROUGH INFORMATION ON THE PROCARD AND THE INITIAL DRAIN FOR (B)(6) 2013 IS 3051ML. THE HOME PATIENT (HP) ONLY DOES A LAST FILL OF 200ML AND THEN A MANUAL DAY FILL OF 2000ML, BUT SHE IS SUPPOSED TO DRAIN THAT OFF BEFORE SHE GETS ON THE HC. THE RN STATED THAT THE HP DID NOT REPORT ANY CURRENT SYMPTOMS. THE LAST VOLUME INFUSED WAS THE MANUAL DAYTIME EXCHANGE WITH A FILL VOLUME 2000ML. THE LARGEST PRESCRIBED FILL VOLUME (LPFV) IS THE NIGHT FILL VOLUME OF 2000ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. 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
    105719 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE