BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 4203058 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37557
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 16, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT LINKED TO THE REPORTED HERNIA UNTIL AFTER THE DEVICE HAD BEEN SERVICED, A COMPLETE DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, AN EVENT HISTORY LOG REVIEW WAS PERFORMED AND THERE WERE NO KEYSTROKES, NO DEVICE FAILURE, MALFUNCTION, PROGRAMMING, USE RELATED OR INCREASED INTRAPERITONEAL VOLUME EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED PROBLEM. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. A SERVICE HISTORY REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT DURING THE SERVICE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A HEART ATTACK MANIFESTED BY WEAKNESS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE HEART ATTACK. TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. HOSPITAL PERSONNEL INFORMED THE PATIENT'S FAMILY THAT THE PATIENT HAD SUFFERED A MYOCARDIAL INFARCTION. IT WAS REPORTED THAT THERE WAS 100% BLOCKAGE IN THE PATIENT'S MAIN ARTERY AND 80% BLOCKAGE IN THE OTHERS. THE PATIENT PERFORMED THERAPY MANUALLY USING UNKNOWN PERITONEAL DIALYSIS SOLUTION ON THE DATE OF THE EVENT. IT WAS UNKNOWN IF THE PATIENT WAS RECOVERED FROM THE MYOCARDIAL INFARCTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681334 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization DIANEAL 2.5% AND 4.25% LOW CALCIUM SINGLEBAG| DIANEAL 2.5% ULTRABAG LOW CALCIUM