BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 6771352 · Received August 7, 2017

    Report

    Report Number
    1212122-2017-00008
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 7, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED AS THERE WERE NO PHOTOGRAPHS OR SAMPLE RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES NOTED FOR THE HEMOCONCENTRATOR, TUBING OR ASSEMBLY OF THE LINES. THE INCOMING RAW MATERIAL DOCUMENTATION WAS ALSO REVIEWED FOR THE TUBING AND HEMOCONCENTRATOR AND NO DISCREPANCIES WERE NOTED. PER THE CARDIOVASCULAR PROCEDURE KIT IFU SECTION 7, THE USER IS DIRECTED TO: ¿INSPECT ALL CONNECTIONS FOR LEAKS OF ANY KIND, FLUID OR GAS, FROM INSIDE THE CIRCUIT TO OUTSIDE, OR VICE VERSA. TIE-BAND AND TIGHTEN ALL CONNECTIONS IN THE CIRCUIT...¿ ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DURING A BLOOD PRIME OF THE HEMOCONCENTRATOR THERE WAS A LEAK BETWEEN THE TUBING AND INLET OF THE PEDIACTRIC HEMOCONCENTRATOR 1ZZ*HC05SA. PER THE REPORT THE PRODUCT WAS NOT CHANGED OUT, INSTEAD A CABLE TIE WAS ADDED TO THE CONNECTION AND IT WAS USED THROUGHOUT THE CASE. THERE WAS AN ESTIMATED BLOOD LOSS OF 1 ML OF THE BANKED BLOOD. THERE WAS NO DELAY IN THE CASE, NO PATIENT INJURY AND THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550429 TERUMO CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 74022-02 VE24

    Patients

    Seq Age Sex Outcome Treatment
    1