BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESPARC SYSTEM

    MDR report key: 12384917 · Received August 30, 2021

    Report

    Report Number
    2531527-2021-00030
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    August 1, 2021
    Report Date
    August 30, 2021
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    KFM
    PMA / PMN Number
    K183623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.10. THE INVOLVED COMPONENT IS MANUFACTURED BY AN EXTERNAL SUPPLIER (TRANSONIC). CONSEQUENTLY, SCAR 220003 HAS BEEN ISSUED TO THE INVOLVED SUPPLIER IN ORDER TO TAKE APPROPRIATE CORRECTIVE ACTIONS TO PREVENT FURTHER OCCURRENCES. NO OTHER SPECIFIC ACTION HAS BEEN DEEMED NECESSARY. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. IF ANY ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: THE CONTROLLER WAS REQUESTED FOR PRODUCT ANALYSIS AND THE DATA LOG WAS REVIEWED. THE FAILURE MODE DESCRIBED IN THE COMPLAINT IS CONSISTENT WITH A WATCHDOG TIMEOUT OR OTHER FAILURE OF THE SINGLE BOARD COMPUTER (SBC) WHICH RUNS THE USER INTERFACE SOFTWARE WITHOUT STOPPING DEVICE FUNCTIONALITY. THE LOG FILE SHOWED INFORMATION WHICH WAS CONSISTENT WITH THE FAILURE MODE REPORTED BY THE END USER AND THE FAILURE COULD NOT BE REPRODUCED ON THE RETURNED DEVICE. WHEN THE DEVICE WAS POWERED ON IT FUNCTIONS NORMALLY. ADDITIONAL TESTING WAS PERFORMED TO WRITE TO THE ENTIRE FLASH MEMORY WHILE RUNNING THE DEVICE APPLICATION TO DETERMINE IF A FLASH MEMORY DEFECT WAS PRESENT WHICH WOULD DELAY THE RESPONSE OF SOFTWARE. THIS TEST WAS REPEATED CONTINUOUSLY OVER 6 DAYS WITH NO WATCHDOG TIMEOUT OCCURRING. WATCHDOG CIRCUIT COMPONENTS WERE VISUALLY INSPECTED. MULTIPLE INSTANCES OF SOLDER SPLASH AND SOLDER BALLS WERE FOUND, ALONG WITH FOREIGN OBJECT DEBRIS WHICH APPEARED TO BE METALLIC. THIS WAS LOCATED IN MULTIPLE AREAS ON THE MAIN BOARD. A SOLDER BALL BETWEEN PINS 2 AND 3 ON U125 COULD HAVE CAUSED AN INABILITY OF THE BOARD COMPUTER TO DRIVE OUTPUTS TO THE HARDWARE WATCHDOG, WHICH WOULD CAUSE THE INITIAL ERROR CONDITION REPORTED. THE CHASSY SUBASSEMBLY HAS BEEN REPLACED TO SOLVE THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE REPORTED EVENT WAS A SOLDER BALL BETWEEN PINS 2 AND 3 ON U125 THAT COULD HAVE CAUSED AN INTERMITTENT INABILITY OF THE SBC TO DRIVE OUTPUTS TO THE HARDWARE WATCHDOG.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. CARDIACASSIST INC. MANUFACTURES THE LIFESPARC SYSTEM . THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED REPORT THAT DURING SUPPORT A LIFESPARC CONTROLLER WENT INTO SELF-TEST FAILURE MODE AND PUMP WAS STILL RUNNING. WHILE GOING TO GET THE BACKUP CONTROLLER, THE LIFESPARC CONTROLLER SHUT OFF. THE BACKUP CONTROLLER WAS TURNED ON AND SUPPORT WAS CONTINUED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285777 LIFESPARC SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM CARDIACASSIST INC. 5900-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown