BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2635579 · Received June 29, 2012

    Report

    Report Number
    1423500-2012-13405
    Event Type
    Death
    Date Received
    June 29, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. HOWEVER, IT WAS DETERMINED THE DEVICE WAS OUT OF SPECIFICATION. THERE ARE NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS DOCUMENTED IN THE DEVICE HISTORY RECORD THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4). GLOBAL PHARMACOVIGILANCE PROVIDED THE FOLLOWING INFORMATION REPORTED TO HOME CARE SERVICES ON (B)(6) 2012 FROM THE PATIENT'S WIFE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND "INTESTINES ROTTED INSIDE HIS PERITONEAL CAVITY." ON (B)(6) 2012, THE PATIENT DIED. CAUSE OF DEATH WAS INTESTINAL ISCHEMIA BACTERIAL PERITONITIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A HOSPITAL TECH CONTACTED BAXTER TECHNICAL SERVICES REQUESTING TO GET LOG INFORMATION FROM THE HOMECHOICE (HC) MACHINE. THE TECH WANTED TO MAKE SURE THE FAMILY DID NOT CHANGE ANYTHING, BECAUSE THE PATIENT DIED ON THE HC. ON (B)(6) 2012, BAXTER GLOBAL TECHNICAL SERVICES (GTS) ASSOCIATE (TSA) CALLED CORPORATE PRODUCT SURVEILLANCE (CPS) TO ADVISE THAT SERVICE REQUEST HAD BEEN OPENED PER CALL FROM A BIOMEDICAL TECHNICIAN (BT) REQUESTING HOW TO OBTAIN READINGS FROM A HOMECHOICE MACHINE BECAUSE A PATIENT HAD DIED AND THE BT WANTED ''TO GO THROUGH THE READINGS.'' THE TSA STATED THAT SHE HAD A CALL YESTERDAY FROM A NURSE AT THE SAME FACILITY WHO STATED THAT A PATIENT'S WIFE MIGHT HAVE MANIPULATED MACHINE SETTINGS AND THE NURSE WANTED INFORMATION ABOUT HOW TO CHECK THE READINGS. THE TSA STATED THAT THE BIOMED STATED THAT THE EVENT DATE WAS (B)(6) 2012. ON (B)(6) 2012, PRODUCT SURVEILLANCE (PS) CONTACTED THE HOSPITAL NURSE IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOMECHOICE PATIENT?S (HP) DEATH. ON (B)(6) 2012, THE HP WAS HOSPITALIZED FOR A SCHEDULED PROCEDURE. THE HP WAS USING THE HOSPITAL'S CYCLER AND HAD USED IT DAILY FOR THERAPY ON (B)(6) 2012 THROUGH (B)(6) 2012. ON (B)(6) 2012 DURING PD THERAPY, THE HP WENT INTO VENTRICULAR FIBRILLATION (V-FIB) AND PASSED AWAY. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE NURSE STATED THAT THE DEATH WAS NOT RELATED TO PD THERAPY. THE NURSE TRANSFERRED THE PHONE CALL TO THE NURSE MANAGER. THE HOSPITAL SUSPECTED THAT THE HP'S WIFE WAS MANIPULATING THE CYCLER SETTINGS AND CHANGING HIS FILLS AND DRAINS. THE NURSE MANAGER DID STATE THAT THEY DID NOT BELIEVE THAT THIS CAUSED THE HP'S DEATH, BUT WANTED TO HAVE ACCESS TO THE DEVICE LOG TO CONFIRM. THERE WAS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. ON (B)(6) 2012, GLOBAL PHARMACOVIGILANCE (GPV) CONTACTED THE HOSPITAL NURSE REGARDING THE DEATH. IT WAS UNKNOWN IF THE PATIENT WAS ON A BAXTER DRUG, HOWEVER, THE NURSE CLARIFIED THAT THE PATIENT WAS ON THE HOMECHOICE MACHINE. THE NURSE STATED THE EVENT OF DEATH WAS NOT RELATED TO THE HOMECHOICE MACHINE. ON (B)(6) 2012, GPV CONTACTED THE MECHANICAL ENGINEER AT THE HOSPITAL. THE REPORTER DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE EVENT. ON (B)(6) 2012, PS CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REGARDING THE PATIENT'S DEATH. APPROXIMATELY 8 YEARS AGO, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) PD THERAPY. THE PATIENT PERFORMED PD THERAPY ON THE CYCLER ONLY. THE NURSE CLARIFIED THE REASON FOR HOSPITALIZATION AND SCHEDULED SURGERY WAS TREATMENT OF ISCHEMIC BOWEL. THE ISCHEMIC BOWEL HAD NOT WORSENED WITH THERAPY. ON AN UNKNOWN DATE, THE PATIENT DIED WHILE IN THE HOSPITAL. CAUSE OF DEATH WAS CARDIAC ARREST. A DEATH CERTIFICATE WAS NOT AVAILABLE. ACCORDING TO THE PDRN, THE FATAL CARDIAC ARREST WAS UNRELATED TO PD THERAPY OR ANY BAXTER PRODUCTS. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death DIANEAL PD4 AMBUFLEX