BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP

    MDR report key: 2024283 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03429
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED SINCE ALL SAMPLES WERE DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE ROOT CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) CALLED CORPORATE PRODUCT SURVEILLANCE (CPS) TO RELAY A REPORT RECEIVED FROM A CLINICAL COORDINATOR ON THE SAME DAY FOR UNKNOWN QUANTITY OF MINICAPS WHICH WERE NOTED TO BE CRACKED WHEN DELIVERED TO THE HOME PATIENT (HP) ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT SINCE THE DEFECT WAS NOTED PRIOR TO USE. THERE WAS NO INJURY OF MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE HP STATED THEY HAD 4 MINICAPS WITH CRACKS IN THEM; THEY HAD SAVED THEM AND WILL SEND THEM BACK TO BAXTER. THE HP STATED THEY HAVE CONTINUED THERAPY WITH NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD879916

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP TRANSFER SET