BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS CENTRIFUGAL PUMP

    MDR report key: 3043023 · Received March 7, 2013

    Report

    Report Number
    1124841-2013-00068
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO WILL BE SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. THE SARNS CENTRIFUGAL PUMP INFO FOR USE (IFU) STATES, "... A STERILE, SINGLE USE DEVICE, USED AS AN EXTRACORPOREAL BLOOD PUMP FOR USE IN CARDIOPULMONARY BYPASS SURGERY FOR UP TO SIX HOURS." BASED ON THE INFO RECEIVED, THE DEVICE IN QUESTION WAS USED FOR A TIME EXCEEDING THE TIME STATED ON THE IFU. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) THE CENTRIFUGAL PUMP SQUEALED. THE PT WAS PUT ON PCPS IN THE EVENING OF (B)(6) 2013, AND THE CENTRIFUGAL PUMP IN QUESTION STARTED TO SQUEAL ON THE MORNING OF (B)(6) 2013. THE PUMP WAS CHANGED OUT ON THE EVENING OF (B)(6) 2013. THE PRODUCT WAS CHANGED OUT. LESS THAN 1CC BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98432 SARNS CENTRIFUGAL PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. NA PC27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK