BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3973805 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25126
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED ON AN UNKNOWN DATE IN (B)(6) 2014 THE PATIENT HAD OUTPATIENT ABDOMINAL HERNIA REPAIR. THE PATIENT RECOVERED FROM ABDOMINAL HERNIA ON AN UNKNOWN DATE IN (B)(6) 2014. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. A SERVICE HISTORY REVIEW WAS PERFORMED AND IT WAS NOTED THAT THE PATIENT HAD RECEIVED THE DEVICE IN NEW MANUFACTURE CONDITION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED NO NONCONFORMITIES, FAILURES, REWORKS OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED HERNIA COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT, ON AN UNREPORTED DATE IN (B)(6) 2014 (PREVIOUSLY REPORTED AS IN (B)(6) 2014), THE PATIENT HAD HERNIA SURGERY AS A TREATMENT FOR UMBILICAL AND ABDOMINAL HERNIA. ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM THE SURGERY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED UMBILICAL AND ABDOMINAL HERNIAS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). THE REPORTED UMBILICAL AND ABDOMINAL HERNIAS OCCURRED PRIOR TO THE PATIENT BEGINNING PD THERAPY. IT WAS REPORTED THE HERNIAS WORSENED DUE TO PD THERAPY. THE PD NURSE REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS UNDERGOING SURGERY TO ¿REMOVE THE HERNIAS¿. THE CAUSE OF THE WORSENING HERNIAS WAS UNKNOWN. PER THE PDRN, THERE WERE NO IIPV EVENTS THAT OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HERNIAS. ON AN UNKNOWN DATE, DURING THE MONTH PRIOR TO RECEIPT OF THIS REPORT, PD THERAPY WAS DISCONTINUED. THE FIRST DAY OF THE MONTH (SAME MONTH AS REPORT RECEIVED) HEMODIALYSIS WAS STARTED DUE TO WORSENING HERNIAS. AT THE TIME OF THIS REPORT THE OUTCOME FOR THE HERNIA EVENTS WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450513 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTIONS