BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3191889 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16511
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF THIS BATCH. UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED THAT SHE PRESENTED WITH PERITONITIS MANIFESTED BY PAIN IN THE ABDOMEN, FEVER AND CLOUDED FLUID, WHICH SUBSEQUENTLY RECURRED. THE HP WAS HOSPITALIZED FOR FOUR DAYS AND WAS TREATED WITH UNKNOWN INTRAVENOUS (IV) ANTIBIOTICS. AFTER BEING RELEASED FROM THE HOSPITAL THE HP CONTINUED TREATMENT WITH UNKNOWN ORAL ANTIBIOTICS. THE HP'S (UNKNOWN) SYMPTOMS DID NOT RESOLVE AND EIGHT DAYS LATER THE HP RETURNED TO THE HOSPITAL, WAS TREATED WITH UNKNOWN INTRAVENOUS (IV) ANTIBIOTICS AND WAS RELEASED AFTER THREE DAYS. AFTER THE HP WAS DISCHARGED FROM THE HOSPITAL THE HP WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS AT THE DOCTOR'S OFFICE FOR THE NEXT 10 DAYS. THE HOME PATIENT IS REPORTEDLY RECOVERING. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290444 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R LOW CA 1.5% 1.5L/2L UB DIANEAL| LOW CA 2.5% 1.5L/2L UB DIANEAL| LOW CA 2.5% 2.5L/3L UB DIANEAL| DIANEAL LOW CA 1.5% DEX 6L/6L| DIANEAL LOW CAL 2.5% DEX 6L/6L| DIANEAL LOW CA 4.25% 6L/6L| LOW CA 4.25% 1.5/2L UB DIANEAL| LOW CA 1.5% 2.5L/3L UB DIANEAL