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

Model Number	L20H-002X01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2019
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, blue, with lot number 00067773 was used from (b)(6) 2018 to (b)(6) 2019 (166 days).We have reviewed the production records of the excor driving tube with the lot number 00067773.This driving unit was produced according to our specification.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, small cracks were detected on the surface of the tubing close to the break, which indicate that a high degree of movement must have occurred at this region.The cause of the defect was most likely due to the positioning of the driving tube in combination with the movement patterns of this patient.In this case, the exact cause of the defect cannot be determined.According to the "important safety information" in the instructions for use, the user is cautioned to avoid risk of damage and obstructions of air and blood flow ensure that blood pumps, cannulae, cannula extension sets, connecting sets and driving tubes are not subject to external forces, like compression,traction or torsion forces, and are free of knots or sharp bends.Prevent the cannulae and connectors from being exposed to tensile forces.Otherwise there is a risk of damage and obstruction of the air and blood flow.
Event or Problem Description
Berlin heart inc.Was informed by the clinic via hotline that a crack was detected in the driving tube of the excor blood pump of a patient supported in the lvad configuration.The patient was stable and the crack was reinforced by the clinic.The pump function was not affected with complete emptying and filling.The driving tube was changed without incident by experienced personnel in the clinic.The patient was not negatively affected by the exchange and is doing well.

• Brand Name: BERLIN HEART EXCOR DRIVING TUBE, RED
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART INC.; 9391 grogan's mill road; suite a-6; the woodlands TX 77380
• MDR Report Key: 8343751
• Report Number: 3004582654-2019-00014
• Device Sequence Number: 2105750
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 09/30/2020
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00067773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 02/15/2019
• 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
• Patient Weight: 12