BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3180621 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16024
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED BY THE CUSTOMER AND WAS UNAVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED THE EVENT DURING THE MONTH OF (B)(6) 2013. AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE MINICAP WAS IDENTIFIED. AS THE MINI-CAP WAS NOT RETURNED, A SAMPLE EVALUATION CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) GD893891 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A CONNECTION ISSUE WITH A MINI-CAP THAT FELL OFF WHILE THE PATIENT WAS DOING THERAPY FOR PERITONEAL DIALYSIS. THE CAUSE OF THE DISCONNECT WAS UNKNOWN AND IT WAS REPORTED THAT THE TRANSFER SET WAS NOT SUSPECT IN THE EVENT AS THERE WERE NO ISSUES NOTED WHEN USING OTHER MINI-CAPS. THE PATIENT RECEIVED PRECAUTIONARY MEDICATION TO PREVENT INFECTION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279721 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE, MINICAP TRANSFER SET