BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4200614 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37323
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER GD897124 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. THE BATCH REVIEW DID NOT VERIFY THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. AS A RESULT, THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER GD897124 WAS MANUFACTURED BETWEEN 05/30/2014 AND 06/06/2014. 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 DISCONNECTED FROM THE MINICAP HOUSING. THE ISSUE WAS DISCOVERED UPON OPENING THE MINICAP POUCH. THE MINICAP WAS DISPOSED OF PRIOR TO USE. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678669 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD897124

    Patients

    Seq Age Sex Outcome Treatment
    1