BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3407995 · Received October 14, 2013

    Report

    Report Number
    1416980-2013-28147
    Event Type
    Injury
    Date Received
    October 14, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BAXTER HAS CONDUCTED A TREND REVIEW. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. REVIEW OF THE DEVICE SERVICE HISTORY AND DEVICE HISTORY RECORD REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF A HERNIA. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE. IT IS UNKNOWN IF THE HERNIA WAS PRE-EXISTING TO THE START OF PD THERAPY. THE HERNIA WORSENED WITH PD THERAPY. THE PATIENT WAS HOSPITALIZED AND REQUIRED SURGICAL REPAIR OF THE HERNIA. PD THERAPY WAS TEMPORARILY DISCONTINUED AND THE PATIENT WAS PLACED ON BACK-UP HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICES CENTER REGARDING THE HOME PATIENT (HP) NEEDED TO DRAIN BEFORE GOING TO THE HOSPITAL FOR SURGERY, WHICH OCCURRED ON THE HOME CHOICE DURING DWELL 4 OF 4. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) BYPASSED THE HP INTO DRAIN STATE FROM DWELL 4 OF 4. THE HP WOULD DISCONNECT EARLY TO MAKE IT TO THE HOSPITAL ON TIME. THE HOME PATIENT WAS CONTACTED ON (B)(6) 2013 IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOME PATIENT?S (HP) REPORT OF A HERNIA REPAIR. THE PATIENT STATED THAT HE STARTED PD THERAPY ONE YEAR AGO AND WAS NOT SURE IF THIS HERNIA WAS PRE-EXISTING PRIOR TO THE START OF PD THERAPY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013, HAD THE HERNIA REPAIR ON THE SAME DAY AS ADMISSION AND WAS DISCHARGED HOME ON (B)(6) 2013. THE PATIENT HAS BEEN PLACED ON BACK UP HEMODIALYSIS THERAPY UNTIL HE IS FULLY RECOVERED FROM THE HERNIA REPAIR. ONCE THE PATIENT IS FULLY RECOVERING HE PLANS TO RETURN TO PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT HE IS RECOVERING FROM THE SURGERY. THE PATIENT STATED THAT THERE WERE NO OVERFILL EVENTS FROM THE HOME CHOICE CYCLE BUT THAT REPORTED THAT HIS HERNIA WORSENED FROM PD THERAPY. PER THE PATIENT, HE RECALLS USING REGULAR DIANEAL PD SOLUTIONS WHEN HE WAS PERFORMING PD THERAPY PRIOR TO THE HERNIA REPAIR (ALTERNATING 1.5%, 2.5%, AND 4.25%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525915 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R DIANEAL1.5%, 2.5%, AND 4.25%