BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 520579 · Received January 8, 2004

    Report

    Report Number
    1423500-2004-00013
    Event Type
    Other
    Date Received
    January 8, 2004
    Date of Event
    December 1, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FAMILY MEMBER OF A HOME PT (HP) REPORTED THE HP EXPERIENCED ABDOMINAL PAIN DURING FILL AND DRAIN WHILE USING THE HOMCHOICE CYCLER FOR APD THERAPY. THE HP REPORTED EXPERIENCING ABDOMINAL PAIN DURING FILL AND DRAIN SINCE 2003 WHEN PT STARTED APD THERAPY. THE HP'S FAMILY MEMBER RELATED THAT THE HP'S ABDOMINAL PAIN DURING THE RECOVERY PERIOD FROM THE SURGICALLY IMPLANTED PERITONEAL DIALYSIS CATHETER WAS NORMAL AND EXPECTED, HOWEVER, THE PAIN CONTINUED ON THROUGH EVENT DATE. THE HP'S FAMILY MEMBER SUSPECTED THAT THE HOMECHOICE CYCLER WAS FILLING THE HP TOO FAST, SO THEY SUBSEQUENTLY REQUESTED A REPLACEMENT DEVICE. THE HP'S FAMILY MEMBER RELATED THAT THE HP HAD A STANDING PRESCRIPTION FOR VICODIN FROM THEIR INITIAL CATHETER IMPLANT IN 2003 AND FOR THE SURGICAL REMOVAL OF A ENDOMETRIAL TUMOR THE FOLLOWING MONTH. ON OCCASION, THE HP CONTINUES TO TAKE THE VICODIN FOR RELIEF OF THEIR ABDOMINAL PAIN. FOLLOW UP WITH BOTH THE HP'S FAMILY MEMBER AND THE HP'S HEALTHCARE PROFESSIONAL (HCP) REVEALED THERE WAS NO RESULTING PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other FLEXICAP DISCONNECT CAP, 2003.| HOMECHOICE APD SET WITH CASSETTE 4-PRONG, 2003.| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2003.| 15L APD DRAINAGE BAG, 2003.| MINICAP DISCONNECT CAP, 2003.