BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP

    MDR report key: 2950466 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03298
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS - NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE NO SAMPLES WERE RETURNED TO BAXTER, REVIEWS OF MANUFACTURING RECORDS REVEALED NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE, AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT OF FATAL PERITONITIS COINCIDENT WITH DIANEAL THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT DIED DUE TO THE PERITONITIS AND OTHER COMPLICATIONS (NOT SPECIFIED). ADDITIONAL INFORMATION WAS OBTAINED BY BAXTER FROM A NURSE. ACCORDING TO THE HOSPITAL, THE REPORTED CAUSE OF DEATH WAS LISTED AS AN ABDOMINAL INFECTION (PERITONITIS), PERFORATED BOWEL, DIVERTICULAR DISEASE, AND GALLBLADDER WITH SECONDARY CAUSE OF GASTROINTESTINAL (GI) HEMORRHAGE. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS BUT WAS, HOWEVER, GIVEN THE ANTIBIOTICS CEFEPIME AND FLAGYL (DOSES, FREQUENCIES, ROUTE AND LOT NUMBERS NOT REPORTED). PER THE RN, THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54712 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R DIANEAL PD2 1.5% AND 2.5%