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

Model Number	D03I-111
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2021
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 driver was performed by berlin heart inc service engineers on (b)(6) 2021, according to the manufacturer specifications.Upon receiving the ikus driving unit at berlin heart inc facility, it was thoroughly inspected externally and internally.Upon start-up, driving unit passed the self-test without any errors and ikus operated properly.The ikus ran for several hours without any alarms or errors.Driving unit was evaluated in consultation with an engineer from the manufacturer of the ikus driving unit, berlin heart gmbh.Upon review of the log files, it was found that there were pressure alarms on august 7th, 12th, 13th, and 16th but all of them were self-corrected.They also showed multiple flow alarms but couldn't find any indication of an ikus pause or stop.After discussion with berlin heart gmbh service engineer, ikus ran on mock loop with the same ikus setting used at the site 220/-40/90/35% for 24hours.It ran without any errors and the ikus never stopped or paused during the duration of the test.After that all the inner tubing and connections were checked and no issues were found.However, during the pneumatic test per the internal procedure, it was found that the left curve was slightly low.Therefore, as a precaution, the over pressure valve was changed.The engineer then repeated continuous operation test on the mock loop with the same setting as before for a 48 hour.The ikus ran without any issues including no alarms, stops or pauses during the run.Based on the test findings & review of the log files, the customer complaint could not be confirmed.In case of a failure of the ikus stationary driving unit, the customer is instructed per the instructions for use (ifu) to switch to the backup ikus provided.
Event or Problem Description
Berlin heart inc.Was informed by the site about an issue with the stationary driving unit ikus of a patient supported with the excor system.The site reported that the blood pump had paused for one minute.The patient remained clinically stable.The ikus was alarming "check left pump and left driveline." afterward, the pump restarted.The bedside nurse at the site also reported there were no kinks of either the cannula or driveline.

• 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
• MDR Report Key: 12469591
• Report Number: 3004582654-2021-00043
• Device Sequence Number: 20018468
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 faci
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 08/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 MO
• Patient Weight: 10