MAUDE Adverse Event Report: BERLIN HEART GMBH BERLIN HEART EXCOR DRIVING TUBE, RED; VENTRICULAR ASSIST DEVICE

Model Number	L20H-002X01
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2016
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).The excor driving tube, lot number 00029425, was used from 10/14/2015 to 3/1/2016 (140 days).Review of the lot history record for this lot and the manufacturing process did not show any discrepancy or any problem related to manufacturing.The driving tube split at a known position near the transition from the thicker to the thinner segment.This area of the driving tube is where the most stress is applied by external forces during use.Excessive external forces can cause a split in the driving tube.Based on findings of similar complaints, manufacturer has implemented a corrective action and changes were approved by the fda reference # h100004 / s011.The lot 00029425 was manufactured prior to this change.
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) to inform that they heard a hissing noise coming from the drive line.Ca suggested to change the drive line.The drive line was changed without incident.The site reported that after the drive line change the hissing noise stopped and small crack was found in the old driving tube near the connection at the pump.The pump was fully filling and ejecting throughout the event and there was no untoward effect to the patient.
Additional Manufacturer Narrative
Corrected manufacturing date from 11/21/2016 to 11/21/2013.

• Brand Name: BERLIN HEART EXCOR DRIVING TUBE, RED
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 5537701
• Report Number: 3004582654-2016-00012
• Device Sequence Number: 625355
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2016

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 Expiration Date: 11/20/2016
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00029425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 06/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 20