BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 4132811 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-34015
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY SEVERE ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. ELEVEN DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, ANTIBIOTIC THERAPY WAS ONGOING WITH ORAL LEVOFLOXACIN 500 MG, ONCE EVERY OTHER DAY. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612429 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896936

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DIANEAL AMBUFLEX| TRANSFER SET, TITANIUM ADAPTER, CASSETTE| HOMECHOICE