BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2133157 · Received June 19, 2011

    Report

    Report Number
    1423500-2011-07803
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    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). THE DEVICE HAS BEEN RECEIVED. EVALUATION SUMMARY: THE REPORTED EVENT WAS CONFIRMED. A BATCH REVIEW WAS PERFORMED AND FOUND THAT NO ABNORMALITIES WERE FOUND DURING THE MANUFACTURE OF THIS LOT. BASED ON THE INVESTIGATION PERFORMED, THE ISSUE IS ASSOCIATED TO A POTENTIAL DAMAGE DURING THE MANUFACTURING OF THE COMPONENT. THE ROOT CAUSE WAS DETERMINED TO BE MOLDING ISSUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE IDENTIFIED THREE UNITS OF MINICAPS WHICH WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS ADDRESSING MINICAP 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CUERNAVACA M11B03A

    Patients

    Seq Age Sex Outcome Treatment
    1