BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART IKUS STATIONARY DRIVING UNIT

    MDR report key: 8516380 · Received April 15, 2019

    Report

    Report Number
    3004582654-2019-00029
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040225
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4). IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). UPON RECEIVING, DRIVER WAS THOROUGHLY INSPECTED EXTERNALLY AND INTERNALLY. UPON START-UP, DRIVER FAILED SELF-TEST WITH ALARM "PROBLEM: MAINS VOLTAGE, CHECK POWER AND SWITCH". HOWEVER, THE IKUS WAS RESTARTED 4 MORE TIMES AND PASSED THE SELF-TEST EACH TIME. EVALUATION OF THE LOG FILES WITH CONSULTATION FROM BERLIN HEART GMBH SERVICE ENGINEER, CONFIRMED THAT COMPUTER 2 RESET 5 TIMES ON MARCH 18TH, RESULTING IN THE PUMPS STOPPING SHORTLY FOR 1..2 SECONDS EACH TIME. IT WAS CONFIRMED THAT THAT BOTH RESET BUTTONS OF THE PROCESSOR BOARDS WORK PROPERLY. WORKING WITH BERLIN HEART GMBH SERVICE ENGINEERS, IT WAS DETERMINED TO REPLACE THE FOLLOWING COMPONENTS, COMPUTER 1, COMPUTER 2, AND THE CONTROL BOARD, WHERE THE REPORTED COMPLAINT WAS THE LIKELY FAILURE OF A COMBINATION OF THESE COMPONENTS. AFTER REPLACING THE COMPONENTS, THE PROBLEM WAS CORRECTED AND IKUS COMPLETED 48 OF CONTINUOUS OPERATION WITHOUT ERROR.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N (B)(4). THIS UNIT WAS PRODUCED ACCORDING TO OUR SPECIFICATION. IN CASE OF A FAILURE OF THE IKUS STATIONARY DRIVING UNIT, THE CUSTOMER IS INSTRUCTED PER THE INSTRUCTIONS FOR USE (IFU) TO SWITCH TO THE BACK-UP IKUS PROVIDED. EVALUATION OF THE AFFECTED UNIT IS STILL ONGOING AND A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ABOUT AN ISSUE WITH THE STATIONARY DRIVING UNIT IKUS OF A PATIENT SUPPORTED WITH THE EXCOR SYSTEM. THE CLINIC REPORTED THAT THE IKUS WAS INTERMITTENTLY STOPPING AND ALARMING. THE DRIVELINE DID NOT HAVE ANY LEAKS AND APPEARED TO BE CONNECTED PROPERLY. THE CLINIC SENT LOG FILES TO BERLIN HEART INC FOR FURTHER INVESTIGATION. TRAINED PERSONNEL AT THE CLINIC SWITCHED TO A BACK-UP IKUS DRIVING UNIT WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307807 BERLIN HEART IKUS STATIONARY DRIVING UNIT VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH D03I-111 04260090040225

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO