BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 4197291 · Received October 23, 2014

    Report

    Report Number
    1416980-2014-37131
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 28, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM OF HERNIA. 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 A VENTRAL HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). THIS HERNIA DIAGNOSIS WAS MADE DURING THE TIME THE PATIENT WAS PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY WITH THE HC DEVICE. ELEVEN DAYS PRIOR TO RECEIPT OF THIS REPORT THE HERNIA WAS SURGICALLY REPAIRED. THE PDRN STATED THAT THE HERNIA ¿MAY POSSIBLY HAVE BEEN CAUSED BY BAXTER PRODUCTS OR SOLUTIONS.¿ THIS WAS NOT CONFIRMED, THEREFORE, THE CAUSE OF THE HERNIA WAS UNKNOWN. THE PDRN REPORTED THAT THE PATIENT WAS ¿KEPT DRY¿ AND DID NOT PERFORM PD THERAPY FOR 1 WEEK AFTER SURGERY. AFTER 1 WEEK THE PATIENT WAS RESTARTED ON ¿LOW VOLUME¿ PD THERAPY. THE PDRN STATED THAT THERE WERE NO REPORTS OF OVERFILL EVENTS ON THE PATIENT¿S HC MACHINE, NOR WAS SHE AWARE OF ANY OVERFILL EVENTS PRIOR TO THE HERNIA. AT THE TIME OF THIS REPORT THE OUTCOME OF THIS HERNIA EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676450 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention