MAUDE Adverse Event Report: BERLIN HEART GMBH BERLIN HEART IKUS STATIONARY DRIVING UNIT; VENTRICULAR ASSIST DEVICE

Model Number	D03I-111X00
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The site contacted berlin heart inc.Clinical affairs to report that the patient supported with berlin heart ikus stationary driving unit and with 10 ml excor blood pumps on a bvad configuration showed incomplete fill in both of the pumps, more frequently in the left pump than the right pump.During the event, several alarms were emitted by the ikus driver.During the "check left pump" alarm, the vad system had "little to no fill or eject" with each pump, however, it was still pumping.It was noted however, that the fill was markedly less/insufficient when compared to its performance before the alarm.The hand pump was not used.The ikus driver in question was turned off without retrieving log files and switched out with a back-up driver.The driver exchange went uneventful, and the pumps were filling and ejecting completely.The patient remained stable, and no significant clinical complications were reported.
Additional Manufacturer Narrative
We have reviewed the production records of the excor stationary driving unit, s/n (b)(6) there were no anomalies in production and documentation is according to the manufacturer specifications.Last maintenance on this driver was performed by berlin heart service engineers on (b)(6) 2024 according to the specification.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
Berlin heart inc.Received the excor ikus driver on 2025-01-08 for investigation.Upon receiving, the unit was inspected both internally and externally.The initial startup test was conducted, and the ikus driver successfully passed all checks.Upon reviewing the log data, it was observed that the ikus driver had been in use since 2024-12-12, operating in bvad (biventricular) mode with 10/10 ml pumps and very low-pressure parameters.These settings had been adjusted several times.On (b)(6) 2024, at approximately 5:41 pm, the ikus driver triggered five flow alarms on the left side, which were cleared.This was followed by a pressure alarm caused by the disconnection of the left driveline.The pressure alarm cleared immediately upon reconnection.Subsequently, the ikus driver performed a self-test after the left driveline was reconnected and passed as intended.The flow alarms are suspected to have been caused by patient movement.The pressure alarm, however, was attributed to a brief disconnection of the left driveline.During this brief disconnection, the left pump likely experienced a "little to no fill and eject" state until the driveline was reconnected.The driver responded as designed by generating an alarm during this event.At approximately 5:56 pm, the patient was transitioned to the backup driver.Analysis of the log data from the event and prior indicates that the ikus driver functioned as intended throughout its operation.Since its connection to the patient on (b)(6) 2024, it was observed that, despite the reported issue of non-optimal filling and emptying of the pumps, no adequate attempts were made to adapt the pump parameters.To investigate further, the ikus driver was tested using 10/10 ml mock loops over a 48-hour period.The driver passed all tests without any issues.Based on the findings, the driveline disconnection event appears to have been caused by an external factor and is classified as a "user error.".

• Brand Name: BERLIN HEART IKUS STATIONARY DRIVING UNIT
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 21183172
• Report Number: 3004582654-2025-00004
• Device Sequence Number: 11827849
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: (01)04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: D03I-111X00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 5 KG