BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2071060 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05076
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 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 PRODUCT WAS DELIVERED IN COMPLIANCE WITH ALL REQUIREMENTS; THERE WERE NO IDENTIFIED ISSUES OR DEVIATIONS ASSOCIATED WITH DAMAGE IN THE PRODUCT. IT WAS DETERMINED THAT THE ISSUE IS DUE TO A MISHANDLING OF THE PRODUCT BY THE USER. THIS IS CONSIDERED AN ISOLATED EVENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER (B)(4) TO REPORT THAT THE OVERPOUCH OF THEIR MINICAP WAS DAMAGED; IT LOOKED LIKE IT WAS WET AND THEN DRIED. THERE WAS NOT PATIENT INVOLVEMENT AS THIS WAS DISCOVERED BEFORE USE. THE PRODUCT WAS NOT USED.

    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 M11B19A

    Patients

    Seq Age Sex Outcome Treatment
    1