BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 2780910 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-01989
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORTED CONDITION WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. A REVIEW OF MANUFACTURING RECORDS REVEALED THE DEVICE HAS BEEN REFURBISHED/SERVICED SINCE ITS ORIGINAL MANUFACTURE DATE AND THE DEVICE IS NO LONGER IN ITS ORIGINAL MANUFACTURE CONDITION. THEREFORE, NO MANUFACTURING ISSUES RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. A SERVICE HISTORY REVIEW WAS PERFORMED, REVEALING THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION AND PREVIOUS SERVICING DID NOT CONTRIBUTE TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REQUESTED, BUT WAS NOT AVAILABLE FOR EVALUATION AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED ON (B)(6) 2012, BY BAXTER (B)(4) (CUSTOMER SERVICES) FROM A PATIENT. THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNREPORTED DATE THE PATIENT EXPERIENCED CHEST PAIN WITH DIFFICULTY TO BREATH, ALONG WITH SHOULDER AND LEFT ARM PAIN. ON AN UNREPORTED DATE, THE PATIENT WENT TO THE HOSPITAL. PER THE PATIENT, THE HEALTH CARE PROFESSIONALS SUSPECTED THAT AIR ENTERED IN THE ABDOMINAL CAVITY DURING USE OF THE HOMECHOICE MACHINE. ON (B)(6) 2012, PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S PHYSICIAN REGARDING THE EVENT. THE FOLLOWING INFORMATION WAS REPORTED. THE PHYSICIAN CLARIFIED THAT THE PATIENT WAS NOT HOSPITALIZED AND WAS SEEN IN THE EMERGENCY DEPARTMENT ONLY. THE PHYSICIAN REPORTED THE PATIENT'S SYMPTOMS WERE CAUSED BY THE AIR. NO MEDICAL INTERVENTION WAS PERFORMED. OUTCOME OF THE EVENTS WAS NOT REPORTED. A CAUSALITY ASSESSMENT WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other