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 Consequences Or Impact To Patient (2199)
Date of Event	03/06/2016
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).Upon return the driving unit was thoroughly inspected externally and internally.The ikus was started, passed self-test, and functioned as designed.On further evaluation of the ikus, battery discharge test was performed and revealed that the right battery voltage dropped rapidly below the required voltage value of greater than 10.8 vdc in 60 minutes.The tester aborted the discharge test.The ikus then manually switched to battery mode, the right battery rapidly dropped voltage and ikus alarmed "batteries discharged - use power supply" multiple times, and the low voltage "chirp" alarm could be heard.The ikus stopped functioning and all three pneumatics systems shut down.The ikus was then manually switched to mains power, paused, and restarted.The ikus then began functioning as designed.After consultation with r & d engineer from berlin heart (b)(4), the manufacturer of ikus unit, it was determined that the right battery had failed.Review of the log files showed that the unit had been used on battery mode without allowing enough time for batteries to recharge.This likely caused the right battery to fail."batteries discharged: use power supply" message appeared after several uses of battery mode without proper recharging.The log also showed that the ikus alarmed "batteries discharged - use power supply" more than 20 times before the ikus stopped functioning at site.Customer used power cords other than what berlin heart provided, which were notably longer.This practice not recommended by the manufacturer.The ikus failure caused by the user error, using the ikus in battery mode without allowing enough time for batteries to recharge, as recommended in the ifu 1000721x09 rev 8, page 7.As of 3.24.2016, the patient is stable and had not issues from this incident.
Event or Problem Description
Berlin heart inc.Clinical affairs (ca) received a call on 3/6/2016 that the ikus mentioned above produced an error message "batteries depleted, please connect to mains power supply" while on power supply for 10 or 20 minutes.At the time of this incident, all seven battery leds were on and the ikus was functioning well with no issues.Berlin heart inc.Service engineer reviewed the log files sent by the site and reported that the log files had indicated that the ikus was being used on battery mode multiple times, for approximately 5-15 minutes at a time without allowing fully recharge the batteries.This was communicated to the site.At this time, the site reported that it was using a long power cord and an extension cord to limit battery usage.On (b)(6) 2016, the site called ca to report that the ikus had stopped pumping while on an extension cord and that the nurse used the hand-pump to support the patient until the patient could be transitioned to the back-up ikus.The nurse reported hearing a chirping alarm from the ikus before confirming the excor blood pump had stopped ejecting prior to hand pumping.The patient was placed on the back up ikus and suffered no untoward effects.

• 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: 5539026
• Report Number: 3004582654-2016-00013
• Device Sequence Number: 383805
• Product Code: DSQ
• UDI-Device Identifier: 04260090040225
• UDI-Public: 04260090040225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H100004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/06/2016

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: 03/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2016
• Initial Report FDA Received Date: 03/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO
• Patient Weight: 9