BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3980486 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25345
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896415 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 PERITONEAL DIALYSIS (PD) PATIENT WAS SUSPECTED TO HAVE EXPERIENCED PERITONITIS. IN THE MONTH PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR ANOTHER INDICATION FOR 24 DAYS. ON AN UNKNOWN DATE, THE PATIENT HAD "STAGNANT EFFLUENT" DUE TO POOR DRAINAGE AND WAS TREATED WITH ANCEF IP (DOSE AND FREQUENCY NOT REPORTED) PROPHYLACTICALLY FOR PERITONITIS. THE CAUSE OF THE SUSPECTED PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT HAD COMPLETED THE ANTIBIOTICS AND WAS FULLY RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456388 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention DIANEAL PD4 1.5% AND 2.5% AMBUFLEX| MINICAP TRANSFER SET, HOMECHOICE| HOMECHOICE AUTOMATED PD SET WITH CASSETTE