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

Model Number	D03I-111
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: BERLIN HEART IKUS STATIONARY DRIVING UNIT
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 15955134
• Report Number: 3004582654-2022-00042
• Device Sequence Number: 17975463
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/09/2022

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-111
• Device Catalogue Number: D03I-111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2013
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 12 KG