BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2498799 · Received March 21, 2012

    Report

    Report Number
    1423500-2012-06745
    Event Type
    Death
    Date Received
    March 21, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. THE PATIENT HAD PASSED AWAY ON (B)(6) 2012. THE RN STATED THAT THIS EVENT WAS NOT RELATED TO ANY OF THE BAXTER PERITONEAL DIALYSIS SOLUTIONS THE PATIENT WAS ON. THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCT. THE ISSUE WITH REGARDS TO THE DEVICE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO BAXTER PRODUCTION ANALYSIS LAB (PAL) FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE PATIENT PASSED AWAY ON (B)(6) 2012. NO ALLEGATION WAS MADE AGAINST ANY BAXTER PRODUCT. (B)(4) NOTIFIED PRODUCT SURVEILLANCE OF ADDITIONAL INFORMATION OBTAINED FROM THE REGISTERED NURSE (RN). THE RN REPORTED THE PATIENT PASSED AWAY. THE RN STATED THIS EVENT WAS NOT RELATED TO ANY OF THE BAXTER PERITONEAL DIALYSIS (PD) SOLUTIONS THE PATIENT WAS ON. THE RN DECLINED TO PROVIDE FURTHER INFORMATION. GLOBAL PHARMACOVIGILANCE PROVIDED ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT'S DAUGHTER ON (B)(6) 2012. THE PATIENT'S DAUGHTER REPORTED PERITONEAL DIALYSIS (PD) THERAPY WAS DISCONTINUED ON (B)(6) 2012 AT 7:45 AM. THE PATIENT WAS DRAINED OUT MANUALLY AND THEN, PER THE REPORTER, EXPERIENCED CONVULSIONS. RAPID RESPONSE WAS CALLED AND THE PATIENT WAS TAKEN TO THE ICU. PER THE REPORTER, THE CONVULSIONS WERE NOT RELATED TO PD THERAPY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 8:00AM FOR DIARRHEA, THROWING UP, AND COUGHING. THE PATIENT WAS GIVEN SUBLINGUAL PROMETHAZINE. THE CAUSE OF DEATH WAS REPORTED AS HEART ATTACK, WHICH OCCURRED ON (B)(6) 2012 AT 8:15AM. IN (B)(6) 2009, THE PATIENT BEGAN DIANEAL PD4 AMBUFLEX VIA CYCLER AND DIANEAL PD4 ULTRABAG 12 LITERS NIGHTLY IP FOR END STAGE RENAL DISEASE (ESRD). THE REPORTER CONSIDERED THE EVENTS OF DIARRHEA, THROWING UP, COUGHING, AND HEART ATTACK TO BE UNRELATED TO PD THERAPY. PATIENT DEATH WAS UNRELATED TO PD THERAPY. THE EVENTS OF DIARRHEA, THROWING UP, AND COUGHING WERE NOT RESOLVED AT TIME OF DEATH. THE LAST TIME THE PATIENT DID MANUAL EXCHANGES WAS OVER 1.5 MONTHS AGO. THE PATIENT DIED 15 MINUTES AFTER SHE WAS ADMITTED TO THE ICU. THE NEPHROLOGIST INFORMED THE PATIENT'S FAMILY THAT CAUSE OF DEATH WAS HEART ATTACK, AND NOT RELATED TO PD THERAPY. THE REPORTER GAVE PERMISSION TO CONTACT THE PATIENT'S PD NURSE. ON (B)(6) 2012, (B)(4) RECEIVED A VOICEMAIL FROM THE PERITONEAL DIALYSIS (PD) NURSE AT THE FACILITY STATING THAT PER THEIR COMPANY POLICY SHE CANNOT GIVE OUT ANY PATIENT INFORMATION. SHE IS DECLINING TO PROVIDE ANY INFORMATION REGARDING THIS EVENT. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death DIANEAL LOW CA (B)(4)| LOW CA (B)(4) UB DIANEAL| DIANEAL LOW CA (B)(4)| DIANEAL LOW CA (B)(4)| HOMECHOICE| LOW CA (B)(4) UB DIANEAL| LOW CA (B)(4) UB DIANEAL