BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 529929 · Received June 9, 2004

    Report

    Report Number
    1423500-2004-00600
    Event Type
    Other
    Date Received
    June 9, 2004
    Date of Event
    May 1, 2004
    Report Date
    May 10, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT (HP) CONTACTED BAXTER'S PRODUCT SURVEILLANCE DEPT TO REPORT AN ALLEGED INCIDENT OF AIR INFUSION THAT OCCURRED DURING THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, THE HP BEGAN EXPERIENCING PAIN IN THEIR SHOULDER AND RIB CAGE APPROX 2 HOURS INTO THERAPY. PER THE HP, NO PT LINE EXTENSION SETS WERE USED AND ALL UNUSED SUPPLY LINES WERE CLAMPED OFF. THE HP INDICATED THAT THEY ALWAYS CONFIRMS THE SUCCESSFUL COMPLETION OF PRIME PRIOR TO CONNECTING. THE HP CAREFULLY EXAMINED THE SUPPLIES PRIOR TO USE AND FOUND NOTHING UNUSUAL. DURING THERAPY THERE WERE NO SIGNS OF LEAKS, NOR WAS THERE AIR VISUALLY NOTED IN THE SETUP AT ANY POINT AFTER PRIME. NO ALARMS WERE RECEIVED. THE HP DOES NOT HAVE AN INITIAL DRAIN AS THEY GET ONTO THE CYCLER WITH AN EMPTY PERITONEUM. THE NEXT DAY THE HP REPORTED TO THE DIALYSIS CLINIC WITH CONTINUE PAIN IN THEIR SHOULDER AND RIB CAGE. PER THE HP THEY PERFORMED A "CAT SCAN OR MRI" TO CHECK THE POSITIONING OF THEIR CATHETER. THE CATHETER WAS FOUND TO BE POSITIONED ADEQUATELY, AND AIR WAS NOTED IN THE HP'S CHEST ACTIVITY. PER THE HP, THE PAIN DISSIPATED AFTER APPROX 5 DAYS. NEITHER HOSPITALIZATION NOR MEDICATION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP NA H03I08068

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2004,| CLAMP, 2004,| MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2004,| 15 LITER DRAINAGE BAG, 2004.