BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3120692 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12951
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED PROBLEM OF PARTICULATE MATTER WAS CONFIRMED. THE LABORATORY ANALYSIS OF THE PARTICLES DETERMINED THAT THE ROOT CAUSE OF THE PROBLEM WAS THAT DURING PACKAGING OF THIS LOT, THE MINICAP OFF-LOAD STATION CRASHED, CAUSING MECHANICAL ISSUES. ALUMINUM PARTICLES FROM THE INCIDENT FELL ONTO THE UNCOVERED MINICAPS IN THIS INDEX. FOLLOWING THIS INCIDENT, CLEANING AND INSPECTION PROCEDURES WERE UPDATED AND IMPROVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION IT WAS IDENTIFIED THAT AN UNOPENED POUCH WITH MINICAPS HAD PARTICULATE MATTER INSIDE. THIS MALFUNCTION WAS IDENTIFIED DURING EVALUATION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222321 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893172

    Patients

    Seq Age Sex Outcome Treatment
    1