BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3081168 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10538
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A SAMPLE WAS REQUESTED FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE REQUESTED SAMPLE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMED THE DEVICE TO BE DAMAGED. DUE TO THE CONDITION OF THE SAMPLE, A FUNCTIONAL TEST COULD NOT BE PERFORMED. IT WAS DETERMINED THAT THE CAUSE OF THE EVENT WAS RELATED TO A MANUFACTURING ISSUE. A WORK ORDER HISTORY WAS REVIEWED ON THE MINICAP ASSEMBLY MACHINE WITH NO ISSUES FOUND. A CAPA WAS OPENED TO ADDRESS THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP WAS DISCOVERED TO BE DEFORMED INSIDE OF THE PACKAGE BEFORE USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THE MINICAP APPEARED TO BE COMPRESSED FROM THE HEAT AND STUCK TO THE PACKAGING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182275 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1