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	05/17/2025
Type of Reportable Event	Malfunction
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.The most recent maintenance on this driver was performed according to the specification by berlin heart service engineers on 2024-08-02.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On 2025-05-17 the site contacted berlin heart inc.Clinical affairs to report that an excor ikus driving unit change occurred.According to the site report, the ikus driving unit was in use on a patient supported with a 10 ml excor blood pump, when the driver began audibly alarming continuously and displayed a login error.The site reported that the blood pump membrane stopped moving during the event.The site also reported that they hand pumped the patient while the affected ikus driving unit was switched to the backup unit.Once the backup driving unit was connected, the pump membrane resumed movement as intended.The patient was stable throughout.Bhi ca was notified after the event, and the affected ikus driver was collected as a complaint.
Additional Manufacturer Narrative
Berlin heart received the affected excor ikus driver on 2025-05-22 for investigation.Upon receipt, the unit was inspected both internally and externally.The initial startup test was conducted, and the ikus driver ran for over 48 hours without any issues.A complaint investigation was conducted in collaboration with the sustaining engineering department at the manufacturer, berlin heart gmbh.As the driver needs to be inspected by the software team, the driver was sent to the manufacturer for further investigation on 2025-06-11.Upon reviewing the log data, it was confirmed that the reported pump stopped operating on 2025-05-18 at 08:24:55.After further analysis of the log data, it was observed that the ikus driver suddenly triggered an alarm during operation when the user tried to log in to the system, showing "backup computer faulty".The driver software then began going through the startup process similar to the initial driver startup when turning on the device.The initial startup test began, aborted and started again, this sequence occurring 6 times on 2025-05-18.About 1 min 24 seconds after the initial "backup computer faulty" error, the ikus driver logged the pump parameters 3 times just before the driver was turned off on 2025-05-18 at around 08:27:29.Additional analysis of the log data with the support of a software engineering team at the external service supplier, no evidence indicating a software failure was found.Then, after the final review, it was suspected that the defective "fram" (working memory of the running processing board) led to the control computer switching to start test mode as a result fault and repeatedly aborting and restarting it.The fram on the mp2 main processing board was observed to be the cause of the reported failure.As a result, the mp2 board, mp1 board and the v24 board were replaced.After replacing, the driver was subjected to a 48-hour continuous operation and passed all the tests successfully without any errors.

• 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: 22208645
• Report Number: 3004582654-2025-00030
• Device Sequence Number: 7714736
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: (01)04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/14/2025

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: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2013
• 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: 5 MO
• Patient Sex: Female
• Patient Weight: 4 KG