BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3982382 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25418
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED 4/24/14 - 5/02/14. THE ACTUAL OPENED DEVICE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED WITH NO ISSUES NOTED. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED ON THE ACTUAL SAMPLE AS THE MINICAP POUCH WAS ALREADY OPENED UPON RETURN OF THE DEVICE. AN UNOPENED COMPANION SAMPLE WAS ALSO RECEIVED FOR EVALUATION. VISUAL INSPECTION AND PRESSURE TESTING WERE PERFORMED ON THE COMPANION SAMPLE, AND NO NONCONFORMITIES WERE NOTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IODINE SPONGE WAS FURTHER OUT OF THE CAP THAN IT USUALLY WAS AND IT DID NOT APPEAR TO HAVE AS MUCH IODINE ON THE SPONGE. THE HOME PATIENT (HP) STATED THAT THE SPONGE DID NOT LOOK AS DARK BROWN AS IT NORMALLY WAS. THE HP NOTICED THE ISSUE, RIGHT BEFORE THEY WENT TO USE THE CAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458521 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896936

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE, AUTOMATED PD SET WITH CASSETTE