BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3241943 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19375
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS OF POTENTIALLY ASSOCIATE LOT GD894188. NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION (DETAILS NOT PROVIDED). ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED DUE TO INFECTION. TREATMENT WAS NOT REPORTED. SUBSEQUENTLY THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED TWO DAYS LATER FOR THE PERITONITIS. HOWEVER, THE TREATMENT RENDERED FOR PERITONITIS WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE WITHDRAWN. HOWEVER, THE PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341024 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization MINICAP TRANSFER SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE