BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 3191128 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16459
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE UV FLASH ASSEMBLY POUCH CONTAINING TWO DISCONNECT CAP ASSEMBLIES WAS RECEIVED FOR EVALUATION. THE POUCH WAS VISUALLY INSPECTED. IT WAS NOTED THAT THE POUCH AND ONE OF THE DISCONNECT CAPS WERE CUT. THE CUT IN THE POUCH AND THE DISCONNECT CAP APPEAR TO HAVE BEEN CREATED BY THE SEALING JAWS ON THE SEALING MACHINE. THE ROOT CAUSE OF THIS COMPLAINT IS OPERATOR ERROR. RELEVANT MANUFACTURING OPERATORS WILL BE NOTIFIED OF THE DETAILS OF THIS COMPLAINT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISCONNECT CAP IN THE POUCH WAS DAMAGED WITH PERFORATIONS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289579 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1