BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3882135 · Received June 18, 2014

    Report

    Report Number
    1416980-2014-19424
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED FOR THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. THE HOMECHOICE DEVICE UNDERWENT EXTERNAL/INTERNAL INSPECTION WHICH IT PASSED. THE DEVICE ALSO PASSED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL AND ELECTRICAL TESTING. A SIMULATED THERAPY WAS PERFORMED WITH NO ISSUES. THE REPORTED IIPV COULD NOT BE VERIFIED IN THE LOGS OR DURING THE DEVICE EVALUATION AND THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RECEIVED, AND A DEVICE ANALYSIS IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED SHORTNESS OF BREATH, A BLOATED ABDOMEN, AND HIGH BLOOD PRESSURE DURING DWELL ONE OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE REGISTERED NURSE (RN) INITIATED A MANUAL DRAIN ON THE HOMECHOICE (HC) DEVICE, AND THE HP DRAINED 3800ML WHILE ONLY HAVING A FILL VOLUME OF 2000ML. NOTHING UNUSUAL WAS NOTED DURING TROUBLESHOOTING FOR THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE RN SENT THE HP TO THE HOSPITAL AS A PRECAUTION, BUT THERE WAS NO PATIENT INJURY INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358329 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1