BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 532693 · Received March 4, 2004

    Report

    Report Number
    1423500-2004-00196
    Event Type
    Other
    Date Received
    March 4, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 5, 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'S (HP) SPOUSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE SUSPICION THAT "AIR IS BEING PUMPED INTO HP" BY THE HOMECHOICE MACHINE DURING THE HP'S AUTOMATED PERTIONEAL DIALYSIS (APD) THERAPY. FOLLOW UP WITH THE HP REVEALED THAT THE HP HAS BEEN EXPERIENCING SHOULDER PAIN SINCE THE INITIATION OF APD THERAPY SEVERAL MONTHS AGO. PER THE HP, THE SHOULDER PAIN BEGAN IN THE RIGHT SHOULDER, THEN APPROXIMATELY 6 MONTHS AGO THE SHOULDER PAIN MIGRATED TO THE LEFT SIDE. THE SHOULDER PAIN ALWAYS APPEARED DURING THE MIDDLE OR END OF APD THERAPY. BAXTER'S PRODUCT SURVEILLANCE DEPARTMENT WENT OVER THE HP'S TYPICAL APD THERAPY SETUP PROCEDURE WITH THE HP, NO ABNORMALITIES WERE REVEALED. THE PT OCCASIONALLY USES THE LINE EXTENSION SET AND THEY ARE CONNECTED DURING PRIME. SUCCESSFUL COMPLETION OF THE PRIME CYCLE IS ALWAYS VERIFIED PRIOR TO CONNECTING TO THE SETUP. PER THE HP, THEY HAVE NEVER RECEIVED ANY AIR DETECT ALARMS. THE HP ADVISED THAT THEY HAVE ON OCCASION NOTED AIR BUBBLES TRAVELING FROM THE 2ND SOLUTION BAG, WHILE IT IS EMPTY, TO THE HEATER BAG DURING REPLENISH, HOWEVER, NO ALARMS WERE RECEIVED. THE HP DOES USE OUTLET PORT CLAMPS DURING CONNECTION OF SPIKE/PORT INTERFACES, AND HAS NEVER NOTED ANY EXCESSIVE MOISTURE AROUND ANY OF THE SOLUTION BAGS OR ANYTHING THAT WOULD BE INDICATIVE OF A LEAK. THE HP INDICATED THAT THERE HAS BEEN NO MEDICAL INTERVENTION FOR THE SYMPTOMS OF SHOULDER PAIN. THE HP HAS NOW RECEIVED A REPLACEMENT CYCLER, AND, PER THE HP'S NURSE, HAS NOT VERBALIZED ANY FURTHER ISSUES WITH SHOULDER PAIN.

    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 71 YR Other 12 FT. EXTENSION SET, EASY LOCK CONNECTOR, 2004.| HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT, 2004.| CAPD TRASFER SET, 2004.| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2004.