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

Model Number	D03I-111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	08/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The site initially contacted clinical affairs (ca) to report that the" pump stopped working", and the patient was being supported using the hand pump.Ca heard that the ikus was audibly alarming in the background.The site could not specify if the blood pump or the ikus unit had stopped working.Per the site, the patient was receiving cpr while being hand pumped; however, the site caller was unable to verify if the blood pump was achieving complete fill and ejection during hand pumping.Prior to initiation of hand pumping and cpr, the nurse entered the patient's room and noted the patient was "posturing, seizing and rigid," and thus, a code was called.The patient was supported via hand pump for approximately 10-15 minutes, while the backup ikus was prepared.The backup ikus was programmed to the patients' current vad settings and connected to the patient.The site reported that, once the backup ikus was connected to the patient, the blood pump was functioning as expected with full fill and full ejection.The ikus unit in question was restarted to collect the log files which were downloaded and sent to bhi for review by the service engineers.Of note, prior to downloading the log files, the ikus was turned off to stop it from alarming.When the unit was restarted to collect the log files, the machine passed the self test and started without incident.The ikus unit was collected on complaint.
Additional Manufacturer Narrative
When the ikus was received from the site, it was started, passed the self test and functioned as expected without any incident.The product at the manufactures request, was sent to the manufacturer, berlin heart gmbh for evaluation.Currently, evaluation of the ikus is being planned, however the device is being held in quarantine as berlin heart has received legal notice to preserve the device in the condition that it was received.The manufacturer will proceed with the evaluation once we have permission to do so.According to the clinic patient was withdrawn from support on (b)(6) 2022 due to an anoxic brain injury.A detailed evaluation report will be provided as soon as it is available.

• 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: 15465402
• Report Number: 3008454189-2022-00012
• Device Sequence Number: 17853185
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/21/2022
• Report Date (Section F): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/30/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2022
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 18 KG
• Date Report Sent to FDA: 09/21/2022