BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3940117 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-22941
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION IS NOT YET COMPLETE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE, AND THE PRESENCE OF IODINE WAS DETECTED. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE POUCH WAS ALREADY OPENED UPON RETURN. PRODUCTION RECORDS WERE REVIEWED, AND ALL BETADINE WEIGHT CHECKS WERE WITHIN THE ACCEPTABLE RANGE. A BATCH REVIEW WAS CONDUCTED, AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON COMPLETION OF THE INVESTIGATION, THE REPORTED ISSUE COULD NOT BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MINICAP WAS DRY. THE HOME PATIENT (HP) REPORTED THAT THE EVENT OCCURRED DURING SET UP, UPON OPENING OF THE PACKAGING OF THE MINICAP. THE HP STATED THERE WAS A SLIGHT BROWNISH COLOR ON THE SPONGES BUT THEY WERE DRY. THE HOME PATIENT (HP) INDICATED THEY STORED THE PRODUCT AT ROOM TEMPERATURE AND AWAY FROM SUNLIGHT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 17 OF 24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418230 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896845

    Patients

    Seq Age Sex Outcome Treatment
    1