BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3551767 · Received January 3, 2014

    Report

    Report Number
    1416980-2014-00354
    Event Type
    Injury
    Date Received
    January 3, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL AND CORRECTED INFORMATION: THE PATIENT LINE WAS NOT PROPERLY PRIMED BEFORE THE PATIENT CONNECTED TO THE PATIENT LINE. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PAIN DUE TO AIR IN THE PATIENT LINE COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAREGIVER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) AND RECEIVED ASSISTANCE ENDING THERAPY. THAT SAME DAY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AND RECEIVED MORPHINE IM (DOSE, FREQUENCY NOT REPORTED) FOR PAIN DUE TO AIR. NO ADDITIONAL INFORMATION WAS PROVIDED. A CUSTOMER CONTACTED BAXTER¿S TECHNICAL SERVICE CENTER REGARDING ASSISTANCE TO END THERAPY. THE PATIENT WAS CONNECTED IN DWELL 1. THE CARE GIVER (CG) STATED THAT WHEN THE HOME PATIENT (HP) CONNECTED TO THE PATIENT LINE AND STARTED THERAPY, THERE WAS AIR IN THE PATIENT LINE. THE HP WAS IN DWELL 1 AND WAS HAVING PAIN DUE TO THE AIR. THE CG STATED THAT HE HAD REMOVED THE SUPPLIES AND WAS REQUESTING ASSISTANCE IN ENDING THERAPY SO HE COULD RESTART WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN ENDING THE THERAPY. THE HP WOULD RESTART WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3407 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention DIANEAL PD4 1.5%, 2.5% AMBUFLEX, EXTRANEAL