BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 3023539 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07439
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED THERE WERE CRACKS ON THE MINICAP NOTED. FUNCTIONAL TESTING WAS PERFORMED AND ALL CRITICAL DIMENSIONS WERE MEASURED AND WERE FOUND TO BE WITHIN THE SPECIFIED TOLERANCES PER THE RELEVANT MINICAP DRAWING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    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. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAK DURING PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT A POVIDONE IODINE LEAK FROM A CRACK ON THE MINICAP WAS FOUND DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126823 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12H29H17

    Patients

    Seq Age Sex Outcome Treatment
    1