BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART IKUS STATIONARY DRIVING UNIT

    MDR report key: 15955134 · Received December 9, 2022

    Report

    Report Number
    3004582654-2022-00042
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 9, 2022
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040225
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N (B)(4). LAST PREVENTIVE MAINTENANCE ON THE DEVICE WAS PERFORMED BY BERLIN HEART INC. SERVICE ENGINEERS ON 07/12/2022, ACCORDING TO THE MANUFACTURER SPECIFICATIONS. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE UNIT, IKUS 12-3690 WAS THOROUGHLY INSPECTED BOTH INTERNALLY AND EXTERNALLY. THE UNIT SUBSEQUENTLY PASSED THE INITIAL STARTUP TEST; IN ADDITION, THE UNIT WAS SUBJECTED TO APPROXIMATELY THREE DAYS OF CONTINUOUS OPERATION ON MOCK LOOP USING VAD SETTINGS AT THE TIME OF THE EVENT WITH NO DISCERNIBLE ISSUES. THEREFORE, CUSTOMER COMPLAINT COULD NOT BE REPRODUCED ALBEIT SAID COMPLAINT WAS CONFIRMED AFTER A REVIEW OF THE IMAGES SUBMITTED BY THE SITE THAT SUBSTANTIATED THE ABNORMAL WAVEFORM, MORE SPECIFICALLY, PRESSURE DROP INDICATING PNEUMATIC ISSUE. DRIVING UNIT WAS EVALUATED IN CONSULTATION WITH AN ENGINEER FROM THE MANUFACTURER OF THE IKUS DRIVING UNIT, BERLIN HEART GMBH. BASED ON INVESTIGATION FINDING CAUSE FOR COMPLAINT WAS DEFECTIVE LEFT PROPORTIONAL VALVE. AFTER REPLACEMENT THE PROPORTIONAL VALVE, DRIVING UNIT WORKED AS INTENDED AND THE IKUS DRIVING UNIT COMPLETED A 48 HOURS CONTINUOUS OPERATION WITHOUT ANY ERRORS.

    Description of Event or Problem · 0

    SITE REPORTED ABNORMAL LVAD WAVEFORM ON IKUS LAPTOP ALONG WITH INCOMPLETE EJECTION OF BLOOD PUMP. BLOOD PUMP MAINTAINED COMPLETE FILLING. PATIENT REMAINED ACTIVE/ENERGETIC AND WAS HEMODYNAMICALLY STABLE WITH BIVALARUDIN DRIP. SITE STATED THAT NO SIGNS OF BLOOD MEMBRANE RUPTURE. NO "SQUEAKING OR CRUNCHING" SOUNDS EMITTED FROM THE BLOOD PUMP. BERLIN HEART RECOMMENDED INCREASING LVAD SYSTOLIC PRESSURE. SITE REPORTED THAT EJECTION WAS SOMEWHAT IMPROVED WITH INCREASE IN SYSTOLIC PRESSURE AND THEY WOULD CONTINUE TO INCREASE AS APPROPRIATE. SITE REPORTED THE NEXT DAY THAT THE PATIENT CONTINUED WITH INCOMPLETE EJECTION. THE LOG FILES WERE REVIEWED BY A BERLIN HEART INC. SERVICE ENGINEER WHO RECOMMEND THE IKUS BE RETURNED FOR INVESTIGATION. THE IKUS WAS SWITCHED TO BACK-UP DEVICE WITHOUT EVENT. THE BLOOD PUMP IMMEDIATELY RESUMED COMPLETED FILLING AND EJECTION. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT AND THE PATIENT CONTINUED TO BE AWAKE/ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2909378 BERLIN HEART IKUS STATIONARY DRIVING UNIT VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH D03I-111 04260090040225

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female