MAUDE Adverse Event Report: BERLIN HEART GMBH CONNECTOR SET FOR CANNULAS Ø 6/9MM; VENTRICULAR ASSIST DEVICE

Model Number	A06-009
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2016
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 connector set (lot no.00050407) was in use from (b)(6) 2016 (59 days).We have reviewed the production records of the excor connector set for cannulas lot 00050407.This connector set was produced according to our specification.The affected connector set was returned to the manufacturer for evaluation.During preliminary visual inspection, no optical anomalies were detected.Detailed evaluation is currently ongoing.
Event or Problem Description
The site informed berlin heart clinical affairs(ca) that there was an exchange of the connector set for cannulas and excor blood pump for a patient supported in lvad configuration.The site reported that a "white spot" was observed on the connecting set 24 hours prior to the event date, which became progressively larger.Upon further inspection, the connector set tubing appeared to have a breach on the inside.The pump performance was maintained as intended throughout the event.Trained personnel at the clinic replaced the affected connector set and excor blood pump.There was no harm to the patient and the patient tolerated the exchange of the connector set well with no untoward effect.The patient is currently doing well.
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 affected connector set was returned still connected to the excor blood pump.At the region of transition of the connecting set tubing to the titanium connectors on both sides (pump inlet and outlet) whitish and reddish-brown residues were observed.The consistency of the residue was tested and found to be similar to a greasy organic substance.There is no evidence of potentially abraded silicon material.It is highly probable that the detected residues originated from an organic substance that was transported by blood and deposited at the transition region amongst other places.No damage such as cuts or breaks could be found at either of the transitions (pump inlet and outlet) of the connecting set tubing to the titanium connector.Tubing was visually inspected under microscope and no defects were detected.No defect of the connector set was detected during the failure investigation.

• Brand Name: CONNECTOR SET FOR CANNULAS Ø 6/9MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 6021782
• Report Number: 3004582654-2016-00037
• Device Sequence Number: 16241136
• Product Code: DSQ
• UDI-Device Identifier: 04260090040591
• UDI-Public: 04260090040591
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2016

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: 10/31/2018
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00050407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 11/03/2016
• 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