MAUDE Adverse Event Report: BERLIN HEART GMBH CONNECTOR SET FOR CANNULA 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	08/18/2016
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 was in use from (b)(6) 2016 (444 days).We have reviewed the production records of the excor connector set (lot no.00039281).This connector set was produced according to our specification.The connector set as was returned to the manufacturer for evaluation.A preliminary visual inspection of the product confirms the sites report of a breach in the connector set above the connector edge of the titanium connector on the blood pump.Detailed evaluation of the returned product is ongoing.
Event or Problem Description
The manufacturer berlin heart (b)(4) was contacted by the site in (b)(6) to report that a small breach was observed in the connecting set tubing which was connected to an excor blood pump on a patient supported in the lvad.The breach in the tubing was above the edge of the titanium connector on the blood pump.The breach was minimal and did not negatively impact the intended care of the patient.Trained personnel at the clinic replaced the affected connector set.There was no harm to the patient and the patient tolerated the exchange of the connecting 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 damage was macroscopically visible and located close alongside the cable-tie securing the driving tube portion to the titanium adapter.The presence of a black cable-tie securing the driving tube portion to the titanium adapter, suggests that the site used a different cable-tie from the standard berlin heart(transparent)cable-tie at the time of the pump exchange performed on (b)(6) 2016.Given the location and the appearance of the damage, it is possible that the incision was caused during the removal of the original cable-tie.

• Brand Name: CONNECTOR SET FOR CANNULA Ø 6/9MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 5952866
• Report Number: 3004582654-2016-00030
• Device Sequence Number: 85162
• Product Code: DSQ
• UDI-Device Identifier: 04260090040591
• UDI-Public: 04260090040591
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/18/2016

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: 09/30/2017
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00039281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 09/28/2016
• 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