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

Model Number	D03I-111
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2013009.Berlin heart inc.(importer number: (b)(4)) is submitting the report on behalf of berlin heart gmbh (manufacturer).We have reviewed the production records of the excor stationary driving unit, s/n (b)(4).This unit was produced according to our specification.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 back-up ikus provided.Evaluation of the affected unit is still ongoing and a detailed investigation report will be provided as soon as available.
Event or Problem Description
Berlin heart inc.Was informed by the clinic about an issue with the stationary driving unit ikus of a patient supported with the excor system.The clinic reported that the ikus was intermittently stopping and alarming.The driveline did not have any leaks and appeared to be connected properly.The clinic sent log files to berlin heart inc for further investigation.Trained personnel at the clinic switched to a back-up ikus driving unit without incidence.The patient was not affected by this incident and is doing well.
Additional Manufacturer Narrative
Exemption number: e2013009.Berlin heart inc.(importer number: (b)(4).Is submitting the report on behalf of berlin heart gmbh (manufacturer).Upon receiving, driver was thoroughly inspected externally and internally.Upon start-up, driver failed self-test with alarm "problem: mains voltage, check power and switch".However, the ikus was restarted 4 more times and passed the self-test each time.Evaluation of the log files with consultation from berlin heart gmbh service engineer, confirmed that computer 2 reset 5 times on march 18th, resulting in the pumps stopping shortly for 1.2 seconds each time.It was confirmed that that both reset buttons of the processor boards work properly.Working with berlin heart gmbh service engineers, it was determined to replace the following components, computer 1, computer 2, and the control board, where the reported complaint was the likely failure of a combination of these components.After replacing the components, the problem was corrected and ikus completed 48 of continuous operation without 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
• MDR Report Key: 8516380
• Report Number: 3004582654-2019-00029
• Device Sequence Number: 2758986
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 03/26/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 5