BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4123545 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33508
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 4, 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 AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN 05/30/2014 AND 06/06/2014. THE EVALUATION OF THE RETURNED MINICAP WAS COMPLETED. NO ABNORMALITIES WERE IDENTIFIED DURING VISUAL INSPECTION, AND IODINE WAS PRESENT IN THE MINICAP SPONGE. FURTHERMORE, VISUAL INSPECTION OF THE OPENED MINICAP PACKAGING REVEALED NO ISSUES. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED ISSUE OF INADEQUATE IODINE WAS UNABLE TO BE VERIFIED DURING SAMPLE ANALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP DID NOT HAVE AN ADEQUATE AMOUNT OF IODINE. THE HOME PATIENT (HP) STATED THE EVENT OCCURRED BEFORE USE. THE HP STATED THEY HAD STORED THE PRODUCT INSIDE OF THEIR HOME IN A TEMPERATURE BETWEEN 68 AND 70 DEGREES FAHRENHEIT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600008 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD897124

    Patients

    Seq Age Sex Outcome Treatment
    1