BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 548329 · Received October 12, 2004

    Report

    Report Number
    1423500-2004-01064
    Event Type
    Other
    Date Received
    October 12, 2004
    Date of Event
    September 12, 2004
    Report Date
    September 12, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING A SWAP OF THEIR HOMECHOICE MACHINE IN 2004 DUE TO RECEIVING A SYSTEM ERROR 2240 ALARM 8 DAYS AGO. REPORTEDLY, THE HOME PT RECEIVED THE ALARM DURING THE INITIAL DRAIN CYCLE OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. THE HOME PT STATED THAT THEIR TRANSFER SET WAS CONNECTED TO THE PT LINE OF THE HOMECHOICE SET DURING THE PRIME CYCLE. AFTER RECEIVING THE SYSTEM ERROR 2240 ALARM DURING INITIAL DRAIN CYCLE THE PT THEN CONTINUED A NEW THERAPY SESSION WITH THE SAME SUPPLIES 8 DAYS LATER THE HOME PT PRESENTED TO THE EMERGENCY ROOM WITH SHOULDER PAIN AND ABDOMINAL DISCOMFORT. THE PT HAD X-RAYS TAKEN AND A SMALL AMOUNT OF AIR WAS NOTED IN THE PT ABDOMINAL CAVITY. THE HOME PT WAS NOT PRESCRIBED ANY PAIN MEDICATION AND THE PAIN DISSIPATED WITHIN 24 HOURS OF THE HOSPITAL VISIT. THE PT'S NURSE STATED THAT THE AMOUNT OF AIR NOTED IN THE PT WAS CONSISTENT WITH THE STANDARD AMOUNT OF AIR IN A DIALYSIS PT. PER THE HOME PT'S NURSE, THE PT HAS FULLY RECOVERED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other 15 LITER DRAINAGE BAG, 2004.| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2004.| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2004.| CAPD TRANSFER SET, 2004.