BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP DISCONNECT W

    MDR report key: 1943149 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07449
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - CUERNAVACA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. SAMPLES WERE RECEIVED BY BAXTER; THE REPORTED ISSUE WAS CONFIRMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS ISSUE WAS RELATED TO (B)(4). A BATCH REVIEW WAS PERFORMED AND NO DEFECTS FOR THE PRODUCT WERE REPORTED DURING THE MANUFACTURING PROCESS. THE INCOMING INSPECTION RESULTS FOR THE COMPONENTS USED DURING PRODUCTION OF THIS LOT WERE WITHIN THE ESTABLISHED REQUIREMENTS. THE LOT WAS CONFIRMED TO HAVE BEEN MANUFACTURED AND RELEASED COMPLYING ALL QUALITY SPECIFICATIONS.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES PRODUCT QUANTITY 5 OF 7. A PATIENT REPORTED TO BAXTER CUSTOMER SERVICE TEAM THAT SHE IDENTIFIED A MINICAP WHICH HAD A RED LINE IN THE PACKAGE AND LOOKED DRY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DISCONNECT W DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CUERNAVACA M10H20A

    Patients

    Seq Age Sex Outcome Treatment
    1