BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3945000 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23358
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE LEFT INGUINAL HERNIA WAS MANIFESTED BY LEFT GROIN DISCOMFORT. ON (B)(6) 2014 THE PATIENT WAS HOSPITALIZED FOR THE EVENT OF LEFT GROIN DISCOMFORT AND OTHER UNRELATED EVENTS. ON UNKNOWN DATES WHILE HOSPITALIZED THE PATIENT RECEIVED " LARGE DOSES OF AN UNKNOWN INTRAVENOUS DIURETIC¿. IT WAS REPORTED THE LEFT GROIN HERNIA HAS NOT WORSENED OR INCREASED. THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WERE RELATED TO THE REPORTED CONDITION. 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT INGUINAL HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THAT THE PATIENT DECLINED SURGERY AND WOULD CONTINUE TO OBSERVE THE HERNIA. THE NEXT DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PD THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421710 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R DIANEAL 4.25% SINGLEBAG (LOW CALCIUM)| DIANEAL 2.5% SINGLEBAG (LOW CALCIUM)| EXTRANEAL