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

Model Number D03I-110

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

Exemption number: (b)(4).(b)(4) (importer number: (b)(4)) is submitting the report on behalf of berlin heart (b)(4)(manufacturer).The stationary driving unit, ikus s/n (b)(4), supported this patient from (b)(6) 2016 until (b)(6) 2017.Preventive maintenance on this driving unit was performed on (b)(6) 2016 and next is scheduled on (b)(6) 2017.Preventive maintenance are performed in every 6 months or every 2000 hours.Log file from this driver was reviewed by r&d engineer from the manufacturer.Log files shows that driver was in battery mode for more than 44 minutes on (b)(6) 2017 (the date of the incident), before connecting to the mains power supply.Log file also shows that driver was set to the pause mode.According to the log file, approximately 25 min.The driver was in the pause mode.It is not clear why the driver was set in the pause mode.However after restarting the driver from pause mode, driver restarted in bivad mode instead of uvad mode and the log files show that "please check left pump and drive tube" and "please connect drive tube" messages were appeared.Based on these messages, at this point the clinic most probably switched to the hand pump.Also it noted that the laptop was turned off for a few minutes, despite of ifu instruction which states that laptop should always be on or active.No technical defects were identified during an analysis of the log files of the ikus driving unit.The driving unit in question has not been received by the manufacturer at the time of this report.Further investigation is pending upon receipt of the driving unit.

Event Description

The manufacturer, berlin heart (b)(4), was informed by the (b)(4) distributor that a problem occurred with the stationary driving unit, ikus of an excor vad patient in (b)(4).The patient returned to the hospital room and the ikus was connected to the main power supply.20 minutes later, the patient complained of a headache and soon after, lost consciousness.The clinical staff examined the blood pump and could not detect any movement of the membrane.No acoustic alarms or abnormalities were displayed on the monitor of the ikus.The patient presented with cyanotic lips indicating reduced support.The hand pump was used to support the patient until transferred to the back-up ikus on site.The patient condition improved following a few strokes with the hand pump.After 5 minutes, the patient was placed on the back-up ikus.Patient condition quickly improved following the transfer to the back-up device.The patient did not suffer irreversible damage during this event and is currently doing well again.

Manufacturer Narrative

(b)(4).Based on log file analysis, the pump stopping was due to the ikus being put into pause mode for about 25 minutes.No technical defects with the ikus were detected during the log analysis.The returned ikus was subjected to testing at berlin heart.The ikus passed the start tests without problems.Additionally, no errors were detected during a 24-hour run test as well.No technical defect of the returned ikus was found.

• Brand Name: BERLIN HEART IKUS STATIONARY DRIVING UNIT
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 200 valleywood rd; suite b100; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 6396937
• MDR Text Key: 69763989
• Report Number: 3004582654-2017-00008
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: H100004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D03I-110
• Device Catalogue Number: D03I-110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 6 YR