BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIFIT STERILE SINGLE USE ADULT THIHGH TOURNIQUET CUFF

    MDR report key: 8567656 · Received April 30, 2019

    Report

    Report Number
    3003748933-2019-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    January 18, 2019
    Report Date
    April 30, 2019
    Manufacturer
    DELFI MEDICAL INNOVATIONS INC.
    Product Code
    KCY
    Removal / Correction Number
    9681444-04/30/2019-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL REPORTED PROBLEM TO (B)(4) DISTRIBUTOR ON (B)(6) 2019 AND DISTRIBUTOR REPORTED THE PROBLEM TO MANUFACTURER ON (B)(6) 2019. MANUFACTURER TESTING OF SAMPLES FROM SAME LOT VERIFIED THE HOSPITAL'S REPORTED PROBLEM WITH SOME DEVICES OF THE LOT. REMOVAL OF ALL DEVICES OF THE LOT INITIATED UNDER 21 CFR 806 REMOVAL REPORT 9681444-04/30/2019-001-R.

    Description of Event or Problem · 1

    TOURNIQUET CUFF SEAM SPLIT AND LOST PRESSURE DURING A TOTAL KNEE REPLACEMENT SURGERY. PATIENT WAS UNDERGOING SURGERY AT THE TIME AND THE CONNECTED TOURNIQUET INSTRUMENT COULD NOT MAINTAIN PRESSURE IN THE CUFF DUE TO THE SEAM SPLITTING. BLOOD ENTERED THE SURGICAL FIELD. THE CUFF WAS REPLACED AND THE EVENT CAUSED A DELAY OF 2-3 MINUTES TO THE PROCEDURE OVER NORMAL PROCEDURE TIME. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360607 VARIFIT STERILE SINGLE USE ADULT THIHGH TOURNIQUET CUFF PNEUMATIC TOURNIQUET CUFF KCY DELFI MEDICAL INNOVATIONS INC. 9-9300-003 18J17

    Patients

    Seq Age Sex Outcome Treatment
    1