BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIFIT STERILE SINGLE USE ADULT THIGH TOURNIQUET CUFF

    MDR report key: 8567651 · Received April 30, 2019

    Report

    Report Number
    3003748933-2019-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    December 19, 2018
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL REPORTED PROBLEM TO (B)(4) DISTRIBUTOR ON (B)(6) 2018 AND DISTRIBUTOR REPORTED THE PROBLEM TO MANUFACTURER ON JANUARY 14, 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

    NEW DISPOSABLE TOURNIQUET CUFF BEGAN SIGNIFICANTLY LEAKING AT THE 80 MINUTE MARK OF A TOTAL KNEE REPLACEMENT PROCEDURE. PRESSURE WAS SET AT 300 MMHG. ANOTHER CUFF WAS USED TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT OR DELAY IN THE PROCEDURE. ON EXAMINING AND RE-INFLATING THE CUFF POST OP, CLINICAL STAFF DISCOVERED A SIGNIFICANT SPLIT ALONG THE SEAM OF THE CUFF. STAFF REPORTED TO DISTRIBUTOR THAT THIS WAS THE THIRD TIME THIS HAD OCCURRED DURING THE WEEK AND A NEW TOURNIQUET CUFF WAS USED FOR EACH CASE. STAFF REPORTED THAT THE LOT NUMBER THEY PROVIDED IS EXPECTED TO BE OF THE SAME BATCH, AS NO PRODUCT NUMBER/LOT NUMBER WAS ON THE DISPOSABLE TOURNIQUET CUFF AND THE PACKAGING HAD BEEN DISPOSED OF BY CLINICAL STAFF PRIOR TO CONFIRMATION OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360614 VARIFIT STERILE SINGLE USE ADULT THIGH TOURNIQUET CUFF PNEUMATIC TOURNIQUET CUFF KCY DELFI MEDICAL INNOVATIONS INC. 9-9300-003 18J17

    Patients

    Seq Age Sex Outcome Treatment
    1