BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 454701 · Received April 15, 2003

    Report

    Report Number
    1423500-2003-00331
    Event Type
    Death
    Date Received
    April 15, 2003
    Date of Event
    February 26, 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 PT (HP) WAS DIAGNOSED WITH PERITONITIS. THE HP EXPERIENCED ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 1 GM AND GENTAMYCIN 80 MG. 2 DAYS LATER, THE HP WAS AGAIN TREATED WITH IP VANCOMYCIN 1 GM. THE HP'S SYMPTOMS DID NOT IMPROVE AND THE HP WAS HOSPITALIZED 3 DAYS LATER. FURTHER MEDICAL TREATMENT IS UNK; HOWEVER, THE RN REPORTED THE HP HAD PERITONEAL DIALYSIS CATHETER REMOVED WAS TEMPORARILY SWITCHED TO HEMODIALYSIS. FURTHER FOLLOW UP WITH THE CENTER DIRECTOR REVEALED THAT THE HP EXPIRED WHILE HOSPITALIZED. THE EXACT CAUSE OF DEATH WAS UNKNOWN, HOWEVER, THE CENTER DIRECTOR INDICATED THE DEATH WAS CARDIAC RELATED.

    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 CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| R MINICAP DISCONNECT CAP, DATES UNK.| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, DATES UNK| 15 L DRAINAGE BAG, DATES UNK,| PD 2 DIANEAL SOLUTION (STRENGTH UNK), DATES UNK,