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

Model Number	D03I-111
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The site contacted berlin heart, inc.Clinical affairs on (b)(6) 2022 to report that the laptop associated with ikus driving unit in question froze when the "enter" key was pressed to acknowledge an entry.Incidentally, the site was transitioning a cannula-only implant from a continuous flow device to a berlin heart system.The ikus driving unit had passed the self-test and completed the two-hour warm up period without issues.The site reported that the "enter" key could not be pushed again, and that the laptop screen was multichromatic with multiple screen images superimposed over one another.The site stated the hand pump was utilized to support the patient until the backup ikus driving unit was ready to be used.The patient remained stable throughout the event.
Additional Manufacturer Narrative
We have reviewed the production records of the excor stationary driving unit, s/n (b)(4).Last preventive maintenance on the driver was performed by berlin heart inc service engineers on (b)(6) 2022, according to the manufacturer specifications.Upon receiving the ikus driving unit at berlin heart inc facility, it was thoroughly inspected externally and internally.Upon startup, driving unit passed the self-test without any errors and ikus operated properly.The ikus ran for several hours without any alarms or errors.The laptop operated properly and "enter" key worked and did not stick as the site reported.Driving unit was evaluated in consultation with an engineer from the manufacturer of the ikus driving unit, berlin heart gmbh.After through troubleshooting, it was determined that there may be an issue with the laptop and intermittently not functioning.All connections were checked and confirmed the complaint was limited to a defect on the laptop.Based on investigation finding cause for complaint was defective laptop and the laptop was replaced.After, replacement, the laptop worked as intended and the ikus driving unit completed a 48 hours continuous operation without any errors.Then performed start-up test several times to ensure that laptop is working properly.In case of an issue with a ikus stationary driving unit, or there is no replacement ikus available the customer is instructed per the instructions for use (ifu) to use a manual pump.

• Brand Name: BLOOD 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: 14744348
• Report Number: 3004582654-2022-00028
• Device Sequence Number: 6636881
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2012
• 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: 2 YR
• Patient Sex: Female
• Patient Weight: 13 KG