MAUDE Adverse Event Report: BERLIN HEART GMBH BERLIN HEART EXCOR ACCESORY SET PU VALVES; VENTRICULAR ASSIST DEVICE

Model Number	TOOL-002
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
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 returned product was a part of the priming set used to prepare an excor blood pump for implantation in a patient.The de-airing set in question was returned with the de-airing tubing connected the 1-way stop cock.The stop cock was separated to perform cleaning of the returned product.No abnormality, such as loose or cracked tubing was detected in this connection.No defects could be detected.Unable to determine the exact cause.
Event or Problem Description
The site contacted berlin heart inc.Clinical affairs (ca) to report that during the implantation of the left excor blood pump of a patient supported in bvad configuration, the stop cock disconnected from the de-airing tubing.Single-step pumping was stopped immediately and no air was introduced into the pump or the patient.The surgeon was able to re-connect the stop cock to the tubing and successfully perform de-airing of the blood pump.The patient was implanted without any issues.

• Brand Name: BERLIN HEART EXCOR ACCESORY SET PU VALVES
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 6640253
• Report Number: 3004582654-2017-00014
• Device Sequence Number: 11089269
• Product Code: DSQ
• UDI-Device Identifier: 04260090040553
• UDI-Public: 04260090040553
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 01/31/2019
• Device Model Number: TOOL-002
• Device Catalogue Number: TOOL-002
• Device Lot Number: 00054359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 40