BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1847011 · Received September 29, 2010

    Report

    Report Number
    1423500-2010-03803
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS NOT RETURNED THEREFORE NO EVALUATION WAS PERFORMED. THE PRODUCT CODE IS UNKNOWN THEREFORE NO 510K NUMBER HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER IS UNKNOWN. THERE IS NO INDICATION OF A DEVICE FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-(B)(4).

    Description of Event or Problem · 1

    INITIALLY, THE REPORTER CONTACTED GLOBAL PHARMACOVIGILANCE (GPV) ON (B)(6) 2010 STATING A HOMECHOICE PATIENT USING A PERITONEAL DIALYSIS (PD) HOMECHOICE PRO DEVICE REPORTEDLY EXPERIENCED A DIASTOLIC BLOOD PRESSURE OF 224. ON (B)(6) 2010, THE PATIENT EXPERIENCED AND OVERFILL (IIPV). ON (B)(6) 2010, THE PATIENT WAS SEEN IN THE DIALYSIS CLINIC. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE REPORTER CLARIFIED THAT THE PATIENT'S BLOOD PRESSURE WAS A SYSTOLIC OF 224 AND DIASTOLIC OF 100 PLUS. REPORTEDLY, THE PATIENT'S DAUGHTER WAS TRAINED TO SET UP THE PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY WITH A HOMECHOICE PRO DEVICE PD4 AMBUFLEX 2500 ML VOLUME FOR A TOTAL OF 4 EXCHANGES NIGHTLY. ON (B)(6) 2010, THE PATIENT CAME OFF THERAPY WITH A TOTAL VOLUME OF 2000ML. THE PATIENT'S DAUGHTER INFUSED ANOTHER 1000ML FOR A TOTAL OF 3000ML VOLUME IN THE PERITONEAL CAVITY. THE PATIENT COMPLAINED OF HIS BACK HURTING AND FELT TIGHT LIKE HE WAS GOING TO BURST. THE PATIENT'S SYSTOLIC BLOOD PRESSURE (BP) WAS 224. THE SAME DAY, THE PATIENT EVENTUALLY DRAINED A TOTAL OF 4100ML. AT THAT TIME THE EVENT OF FEELING LIKE HE WAS GOING TO BURST WAS RESOLVED. ON (B)(6) 2010, THE PATIENT WAS SEEN IN THE PD CLINIC. THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND HAD A SYSTOLIC BP READING OF 211. ON (B)(6) 2010, THE PATIENT'S DAUGHTER TOOK THE PATIENT TO THE EMERGENCY DEPARTMENT (ED) FOR SHORTNESS OF BREATH. THE PATIENT WAS NOT ADMITTED. ON (B)(6) 2010, THE PATIENT WAS DISCONTINUED FROM THE HOMECHOICE PRO AND STARTED ON MANUAL EXCHANGES. THE PATIENT'S CURRENT FILL VOLUME OF 4 EXCHANGES IS 2000ML. THE PATIENT'S SYSTOLIC BP THAT DAY WAS 157 AND THE EVENT WAS CONSIDERED RESOLVED. THE EVENT OUTCOME FOR BACK HURTING AND SHORTNESS OF BREATH WAS ONGOING. ALL EVENTS WERE UNRELATED TO DIANEAL THERAPY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED. NO FURTHER INFORMATION IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention