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	11/28/2017
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 00057902 was used from 2017-01-19 to 2017-11-29 (313 days).The driving tube broke at the transition to the pump connector, where a minimal air leakage is possible.At this region of the driving tube, there is a transition from smaller diameter to larger diameter.This transition area of the driving tube is where the most stress is applied by external forces when in use by a patient.This driving tube lot was manufactured after implementation of changes by the manufacturer in 2015.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.
Event or Problem Description
We were informed by our (b)(4) distributor that flow alarms were noted in a patient supported in lvad configuration.Upon inspection, the clinic detected a defect in the red driving tube at the transition point from the smaller to larger diameter of the driving tube.The driving tube was changed on (b)(6) 2017 without incident by experienced personnel in the clinic.There was no harm to the patient and the patient tolerated the driving tube exchange well with no untoward effect.

• 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: 7129319
• Report Number: 3004582654-2017-00032
• Device Sequence Number: 2037499
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160035
• 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,Followup
• Report Date (Section B): 12/19/2017

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: 07/31/2019
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00057902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR