BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4130665 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33944
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN 6/6/14 AND 6/13/14. AS THE MINICAP WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS PERFORMED, AND IT REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IODINE SPONGE OF A MINICAP WAS DRY. THE ISSUE WAS NOTED BY A REGISTERED NURSE (RN) AFTER THE MINICAP WAS RETURNED BY A HOME PATIENT (HP). THE HP DID NOT USE THE DEVICE AND RETURNED THE MINICAP TO THE RN UNOPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608192 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD897140

    Patients

    Seq Age Sex Outcome Treatment
    1