BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1914877 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06545
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (H10H02023) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS EVENT INVOLVES THREE BAXTER PRODUCTS. THIS MEDWATCH IS BEING SUBMITTED FOR THE FIRST OF THOSE THREE PRODUCTS.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO SUCCUMBED TO SERRATIA PERITONITIS FOLLOWING INFARCTION OF A SEGMENT OF BOWEL AND MYOCARDIAL INFARCTION. THE HOME PATIENT'S DAUGHTER CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A SYSTEM ERROR 2418 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DRAIN 5 OF 13. THE DAUGHTER STATED THAT THE HOME PATIENT (HP) WAS IN THE HOSPITAL AND IS USING THE HOSPITAL HOMECHOICE DEVICE. THE TECHNICAL SERVICE REPRESENTATIVE PERFORMED TROUBLE SHOOTING AND THERAPY WAS RESUMED. THE NURSE STATED THAT THE PATIENT WAS VOMITING, HAD NAUSEA AND DIARRHEA AND WAS VERY WEAK SO SHE WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND HAD A HEART ATTACK ON THAT DAY. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010 LATER DETERMINED TO BE DUE TO LEAKAGE FROM DEVITALIZED BOWEL. THE NURSE STATED THAT THE PATIENT WAS GIVEN AN ANTIBIOTIC BUT WAS NOT GETTING ANY BETTER. THE PATIENT WAS TAKEN OFF OF PERITONEAL DIALYSIS (PD) THERAPY FROM (B)(6) 2010 TO (B)(6) 2010 BUT RESUMED PD THERAPY DUE TO PAIN. IT WAS FOUND THAT THERE WAS STOOL IN THE PATIENT'S PD EFFLUENT. THE PATIENT HAD A CLOT IN HER MESENTERIC ARTERY. THE PATIENT'S INTESTINE INFARCTED REQUIRING SURGERY TO HAVE FOUR FEET OF HER INTESTINE REMOVED. THE PATIENT BECAME MORE ILL AND THE SURGERY DID NOT HOLD AND THE PATIENT ENDED UP PASSING AWAY IN THE HOSPITAL ON (B)(6) 2010. THE SYSTEM ERROR 2418 WILL RESULT IN A FAIL-SAFE SHUTDOWN OF THE DEVICE AND WOULD NOT BE CAUSALLY RELATED TO THESE MEDICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H