MAUDE Adverse Event Report: MC3 INC. MC3; CARDIOVASCULAR CANNULA

Model Number	6384
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the end of a cardiopulmonary bypass surgery, and after the patient was no longer supported by the extracorporeal circuit, it was noticed by the customer that the connector had become separated at the glue joint of the cannula.It is not possible for the manufacturer to confirm the amount of force that was required to break the bond of this particular cannula.Mc3 has manufacturing controls of this bond joint and all information reviewed and testing results confirm that specifications are met.An in depth review of production data, trend data, records and testing did not uncover any root cause of bond strength variation that could have caused the malfunction.With excessive force, it is possible to break the glue joint bond prior to disconnection of the tubing to barb connection.Since the connector was intact throughout the case and there was evidence of glue on the returned device, it is suspected that a force was applied to the bond joint greater than the 20 pound specification limit.The root cause of the problem experienced remains inconclusive.
Event or Problem Description
The malfunction occurred on (b)(6) 2019 and was reported to the distributor by the customer.The distributor forwarded information about this malfunction on (b)(6) 2019 to mc3.The customer described the following: at the end of a cardiopulmonary bypass surgery, when they were removing the mc3 soft flow angled tip arterial cannula , it was noted that the cannula became unbonded.The device was used to complete the case.There were no adverse patient effects.

• Brand Name: MC3
• Common Device Name: CARDIOVASCULAR CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 9617773
• Report Number: 3011468686-2019-00003
• Device Sequence Number: 17002398
• Product Code: DWF
• UDI-Device Identifier: 10854916006260
• UDI-Public: 10854916006260
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K132451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 04/30/2020
• Device Model Number: 6384
• Device Catalogue Number: 6384
• Device Lot Number: 1610105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1