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

Model Number	L20H-002
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
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 00054147, was used from (b)(6) 2016 to (b)(6) 2017 (258 days).The driving tube broke at the transition to the pump connector leading to a minimal leaking of air.At this area of the driving tube, there is a transition from smaller diameter to bigger diameter.This transition area of the driving tube is where most stress is applied by external forces during use on the patient.Upon further evaluation of the driving tube, several small fine surface cracks were detected on the surface of the tubing, close to the defect, which appears to be caused by stresses applied on the tubing.Additionally, the disinfectants or cleaners used might have harmed the surface of the tube.According to the clinic, the patient in question is highly active and mobile.All these factors might have contributed to the break of the tubing.However, exact cause of the defect could not be identified.Lot was made after implementation of changes to drivelines.
Event or Problem Description
Berlin heart was informed by our (b)(4) distributor that a defect was observed in the red driving tube of an excor blood pump on a patient supported in lvad configuration.The clinic provided berlin heart with pictures and video material.Upon reviewing the pictures and the video, it was observed there was a small break in the drive line, near the transition from the thicker to the thinner segment.Ca suggested to change the drive line.The drive line was changed without incident by experienced personnel in the clinic.According to the clinic, the pump function was not affected by this event.There was no harm to the patient and the patient tolerated the drive line exchange well with no untoward effect.We were informed that the patient was successfully transplanted on (b)(6) 2017.

• 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: 6618813
• Report Number: 3004582654-2017-00012
• Device Sequence Number: 95577
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H100004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2017

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: 02/28/2019
• Device Model Number: L20H-002
• Device Catalogue Number: L20H-002
• Device Lot Number: 00054147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR