BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4094045 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31627
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN THE DATES OF 05/30/2014 AND 06/06/2014. THE DEVICE WAS DISCARDED BY THE CUSTOMER; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP WAS DRY UPON OPENING OF THE PACKAGE. THE HOME PATIENT (HP) STATED THEY DID NOT USE THE MINICAP. THE HP STATED THAT THERE WERE NO SIGNS OF DAMAGE TO THE PACKAGING AND THEY STORED THE PRODUCT IN THEIR HOME WHERE THE TEMPERATURE IS 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 2 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571194 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD897124

    Patients

    Seq Age Sex Outcome Treatment
    1