BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3953328 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23884
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD897108 AND GD896704 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. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT 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 COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH BACTRIM ORALLY (DOSAGE AND FREQUENCY NOT REPORTED), INTRAVENOUS (IV) GENTAMYCIN (DOSAGE AND FREQUENCY NOT REPORTED) AND IV TOBRAMYCIN (DOSAGE AND FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. PERITONEAL DIALYSIS THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431667 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, FLEXICAP, MINICAP TRANSFER SET| DIANEAL 2.5% PD4 AMBUFLEX| DIANEAL 2.5% PD4 ULTRABAG