BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 482240 · Received September 3, 2003

    Report

    Report Number
    1423500-2003-00939
    Event Type
    Injury
    Date Received
    September 3, 2003
    Date of Event
    August 5, 2003
    Report Date
    August 6, 2003
    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 PATIENT (HP) CALLED BAXTER TECHNICAL SERVICE TO REPORT THAT THEY RECEIVED AIR IN THEIR DAY FILL 1 OF THEIR DAY FILL 1 OF APD THERAPY WITH THE HOMECHOICE MACHINE ON 2 CONSECTIVE DAYS. HP RELATES THAT PATIENT HAVE A DRY DAY AND PERFORMS A BRIEF INITIAL DRAIN ONLY PRIOR TO THERAPY ADVANCING INTO THEIR DAY FILL 1. HP HAS AN INITIAL DRAIN SET POINT AT 1500ML TO ENSURE SOME DRAINAGE PRIOR TO FILL, BUT BYPASSES THIS DRAIN IF NO FLUID DRAINS AFTER 1 MINUTE OR SO. HP STATES THEY ARE SURE THAT THE PATIENT LINE OF THEIR HOMECHOICE INTEGRATED SET WAS COMPLETELY PRIMED PRIOR TO FILL 1, BUT PATIENT SAW TWO AIR BUBBLES FROM THE PATIENT LINE GO INTO THEM ON BOTH OCCASIONS. HP DESCRIBES THE BUBBLES AS APPROXIMATELY 1/2 INCH IN LENGTH IN THE PATIENT LINE AND THEY WERE UNABLE TO STOP TREATMENT BEFORE THE AIR BUBBLES WERE INFUSED. HP REPORTS THAT PATIENT IMMEDIATELY FELT PAIN IN THEIR SHOULDER AND ARM AFTER THIS OCCURRED AND CONTINUED TO EXPERIENCE PAIN FOR THE FOLLOWING WEEK. APD THERAPY WAS COMPLETED WITH THE INITIAL SET USED IN BOTH INCIDENTS. HP REPORTS THAT ATTEMPTED TO PURGE THE AIR BY RIDING THEIR BIKE AND NO MEDICAL INTERVENTION WAS REQUIRED. HP SWITCHED THEIR SET TO A DIFFERENT LOT NUMBER AND REPORTED NO FURTHER DIFFICULTIES. HP REPORTS THEY NOTED NOTHING UNUSUAL WITH HOMECHOICE SETS USED.

    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 H03D16021

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK) 2003,| MINICAP DISCONNECT CAP, 2003.| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2003,