MAUDE Adverse Event Report: BERLIN HEART GMBH CONNECTOR SET FOR CANNULAS Ø 6/9 MM; 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	03/11/2016
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 for cannula set was in use from (b)(6) 2016 (52 days).We have reviewed the production records of the excor connector set for cannulas s/n (b)(4).This connector set for cannulas was produced according to our specification.The explanted blood pump and the trimmed off section of the connecting set tubing was returned to the manufacturer for evaluation.The returned section of the tubing was visually inspected under a microscope.Through microscopic analysis, a small incision (like a small cut) was detected on the outer surface of the tubing.At the inner surface of the tubing, this damage looked more rupture-like, allowing the drop of blood to leak through.Based on imprints of the cable tie detected on the outside of the tubing, it was determined that position of the incision corresponds to the position where the cable tie is fastened: the imprint is partially overlapping the visible incision and damage.An imprint of unknown origin is also visible on the tubing in the region close to the visible damage there is insufficient evidence to confirm if this tool contributed to the failure.The titanium connector belonging to the connecting set was not returned since still being utilized on the patient.Based on the appearance of the damage the tubing was initially caused by an external cut.Due to this external damage an incision was created, which developed into a tear in the interior of the tubing until the tubing ruptured, by which the site detected a drop of blood on the outer surface of the connector set.
Event or Problem Description
The site called berlin heart clinical affairs (ca) on (b)(6) 2016 to report that the site had changed the excor blood pump on a patient supported in lvad configuration, because a nurse noticed drop of blood on the outside of the connecting set tubing which was connected to outflow side of the pump.The blood drop was, very close to the connecting set titanium connector.The site also reported that the blood could only be produced by bending the cannula away from the site of the blood.The site has reused the connecting set tubing, after trimming off the compromised section of the connector set tubing.There was no harm to the patient and the patient tolerated the pump change well, with no untoward effects issues.

• Brand Name: CONNECTOR SET FOR CANNULAS Ø 6/9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 5563022
• Report Number: 3004582654-2016-00015
• Device Sequence Number: 10939658
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/11/2016

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: 06/30/2018
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00047453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 MO
• Patient Weight: 9