BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI-CAP

    MDR report key: 3153099 · Received June 8, 2013

    Report

    Report Number
    1416980-2013-14608
    Event Type
    Death
    Date Received
    June 8, 2013
    Date of Event
    April 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBERS GD893875 AND GD893743 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: THE PATIENT WAS READMITTED TO THE HOSPITAL AND WAS BEING TREATED (SPECIFIC TREATMENT NOT REPORTED) FOR THE PERITONITIS. PERITONEAL EFFLUENT (PD) CULTURE RESULTS FOR THE PERITONITIS EVENTS MENTIONED WERE UNKNOWN TO THE HUSBAND. THE HOME PATIENT WAS TREATED WITH (UNKNOWN) ANTIBIOTICS FOR BOTH EVENTS. THE HUSBAND STATED THE CAUSE OF DEATH WAS UNKNOWN. AN AUTOPSY WAS NOT PERFORMED AND OFFICIAL DEATH CERTIFICATE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 4. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. THIRTY FIVE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255981 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| R DIANEAL 2.5% LOW CAL AMBUFLEX