MAUDE Adverse Event Report: MC3 INC. MC3 SOFT FLOW; CANNULA CARDIOPULMONARY BYPASS

Model Number	7072
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that there was a leak noticed by the customer during insertion of the device.The returned device could not be tested as the bond had broken by the time it arrived at the lab.There was evidence of glue present on the connection.The customer may have added force to break the connector bond but this is unknown.10 devices from the identical lot were tested and found to meet specification for bond strength.An investigation of this issue was completed that did not reveal any significant finding related to the manufacturer of this lot or any other soft-flow lot that would indicate a cause of bond failure other than forces greater than the specified bond strength.
Event or Problem Description
During insertion of the cannula, a partial separation of the cannula from the connector was identified at approximately 50% of the bond.This occurred during insertion of the cannula when blood was filling the cannula.It was noticed that there was blood around the connection and the surgeon decided to remove the cannula and replaced with another cannula of the same model.This was identified prior to going on pump.There was no adverse patient effect.

• Brand Name: MC3 SOFT FLOW
• Common Device Name: CANNULA CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 11529581
• Report Number: 3011468686-2020-00003
• Device Sequence Number: 4182915
• Product Code: DWF
• UDI-Device Identifier: 10854916006369
• UDI-Public: 10854916006369
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: 07/31/2022
• Device Model Number: 7072
• Device Catalogue Number: 7072
• Device Lot Number: 1907116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1