BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3874575 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19127
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RECEIVED. HOWEVER, 36 COMPANION SAMPLES WERE RECEIVED. A BATCH REVIEW WAS CONDUCTED FOR EACH LOT RECEIVED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED ON ALL SAMPLES. THESE TESTING METHODS WERE UNABLE TO VERIFY THE REPORTED CONDITION, AS THE DEVICES ALL FUNCTIONED WITHIN THE DESIRED PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK WAS OBSERVED IN A MINICAP. THE CRACK WAS OBSERVED BEFORE USE OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352009 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1