BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESPARC PUMP

    MDR report key: 14592931 · Received June 2, 2022

    Report

    Report Number
    MW5110074
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 31, 2022
    Manufacturer
    LIVA NOVA / CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE OUTLET TUBING ON LIFESPARC PUMP APPEARED NORMAL ON FRIDAY ((B)(6) 2022) WHEN WE FIRST AMBULATED OUR PATIENT WITH THE VOYAGER VEST. THE BEDSIDE RN CALLED NOTING BLOOD DRIPPING OUT OF THE OUTLET AREA SATURDAY ((B)(6) 2022) MORNING. OUR TEAM WAS ABLE TO ASSESS. TUBING HAD MIGRATED OFF THE SECOND OUTLET BARB AND WAS JUST MAKING FULL CONTACT WITH THE FIRST OUTLET BARB. SHE WAS ABLE TO GET THE OUTLET TUBING ADVANCED BACK UP TO THE SECOND BARB AND SECURED WITH A ZIP TIE AND BANDING GUN (SHE SECURED THE INLET TUBING AS WELL, JUST TO BE SAFE). TUBING APPEARS TO BE HOLDING WITH NO MOVEMENT WHEN I CHECKED ON OUR PATIENT TODAY. IMPLANT DATE: (B)(6) 2022 ¿ PUMP ON AT 14:30 EVENT DATE: (B)(6) 2022 ¿ NOTED BY DAY SHIFT BEDSIDE RN WHEN TAKING OVER AT SHIFT CHANGE ~7:30 AM PDT PUMP, SN: (B)(4). THIS IS A NEW PRODUCT TO OUR FACILITY. WE HAD PRODUCT TRAINING BY LIVA NOVA CLINICAL CONSULTANT ON (B)(6) 2022. IN THIS TRAINING, THE NEED TO ZIP TIE CONNECTIONS TO PREVENT EGRESS OF TUBING WAS NOT MENTIONED. FOLLOWING THE EVENT, COMPANY WAS NOTIFIED. INITIAL RESPONSE BY CLINICAL CONSULTANT WAS THAT THE CHIEF ENGINEER STATED THAT TUBING SHOULD BE BONDED AND THAT THIS WAS A DEVICE ERROR WHICH WOULD BE FOLLOWED UP ON. FOLLOWING RESPONSES OVER THE NEXT FEW DAYS REVEALED THAT THE UPDATED DIRECTIONS FOR USE (DFU) FOR THE PUMP SPECIFY THAT CONNECTIONS SHOULD BE SECURED WITH ZIP TIES. HOWEVER, THE DFU WE HAD FROM INITIAL PLACEMENT 9 DAYS BEFORE THIS EVENT DID NOT INCLUDE THIS RECOMMENDATION, AND WE WERE NOT TRAINED TO THIS NEW PRACTICE IN THE DFU ON (B)(6) 2022 NOR NOTIFIED OF UPDATED DFU. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161543 LIFESPARC PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVA NOVA / CARDIAC ASSIST, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM-(B)(6) 2021-(B)(6) 2021-(B)(6) 2022