BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3854426 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18264
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    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). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896209, GD896589 AND GD896597 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED AS CLOUDY EFFLUENT AND NOT FEELING WELL COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THREE DAYS AFTER THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH UNKNOWN ANTIBIOTICS FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORTED 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332550 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD4 1.5%, 2.5%, AND 4.25% AMBUFLEX| HOMECHOICE, CASSETTE, TRANSFER SET