BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 3150648 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14517
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 29, 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER GD893990 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS.

    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. FIVE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250638 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization UNKNOWN DIANEAL