BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1913520 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06478
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (GD875567) 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.

    Description of Event or Problem · 1

    THE SISTER OF THE HOME PATIENT CONTACTED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE TO NOTIFY BAXTER OF THE PATIENT DEATH. THE SISTER STATED THAT THE HOME CHOICE HAS BEEN RETURNED TO BAXTER, AND AN AUTOPSY WAS NOT PERFORMED. THE SISTER STATED THAT THE PATIENT HAD PERITONITIS AND COULD NOT RECOVER. THE PATIENT'S PERITONEAL CATHETER WAS REMOVED WHILE THE PATIENT WAS HOSPITALIZED IN THE CRITICAL CARE UNIT AND A HEMODIALYSIS CATHETER WAS PLACED IN HER GROIN. THE PATIENT DIED ON (B)(6), 2010, TEN MINUTES INTO HER SECOND HEMODIALYSIS TREATMENT FROM CARDIAC ARREST. FOLLOW UP INFORMATION WAS OBTAINED FROM THE NURSE MANAGER FROM (B)(6) HOSPITAL AND THE PERITONEAL DIALYSIS NURSE FROM THE CLINIC: THE PATIENT WAS SEEN AT THE CLINIC ON (B)(6), 2010 AND SHOWED NO SYMPTOMS OF PERITONITIS. THE PD CLINIC NEVER DIAGNOSED OR TREATED FOR PERITONITIS. THE PATIENT WAS DOING FINE AND LAB RESULTS WERE GOOD. ON (B)(6), 2010, THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL SHOWING SYMPTOMS OF NAUSEA, VOMITING, DIARRHEA, HYPOTENSION 60/30 AND HYPOGLYCEMIA. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND SEPTIC SHOCK. THE PATIENT WAS TREATED (ANTIBIOTIC UNKNOWN). THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL ON (B)(6), 2010 AND HAD CARDIAC ARREST AND MULTI ORGAN FAILURE. THE CAUSE OF DEATH WAS LISTED AS MYOCARDIAL INFARCTION AND RESPIRATORY FAILURE. THE PERITONEAL DIALYSIS NURSE INDICATED THAT THE PATIENT'S HOME SET UP OF SUPPLIES HAD BEEN VIEWED AND WAS A STABLE AND APPROVED AREA FOR TREATMENT USING THE HOMECHOICE DEVICE AND SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H