MAUDE Adverse Event Report: BERLIN HEART GMBH 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	06/26/2018
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 00060195, was used from 2018-03-12 to 2018-06-26 (106 days).During investigation, a break was detected at the transition to the pump connector.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 had occurred at this region.According to the (b)(4) distributor, the driving tube was stressed due to the sitting position of the patient.This is the second case involving a similar failure scenario, observed with this patient.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.The exact cause of the defect cannot be detected in this case.According to the "important safety information" in the instructions for use, the user is cautioned to ensure that there are no kinks in the blood pumps, cannulae and driving tubes.Otherwise, support could be inadequate.Additionally, users are reminded to ensure that the blood pumps, cannulae and driving tubes are never exposed to tension, torsion, pressure or strain.Otherwise, support could be inadequate or tension may cause damage to the transcutaneous exit site.
Event or Problem Description
We were informed by our (b)(4) distributor that the clinic detected a small leak at the transition point from the smaller to larger diameter of the driving tube.The driving tube was changed without incident by experienced personnel in the clinic.There was no harm to the patient and the patient tolerated the 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: 7707605
• Report Number: 3004582654-2018-00040
• Device Sequence Number: 19229639
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 10/31/2019
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00060195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR