MAUDE Adverse Event Report: SURGE CARDIOVASCULAR / MED MICHIGAN HOLDINGS LLC VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number FEM-V1028

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

It was reported that during the minimally invasive aortic valve replacement case that there was poor drainage of the patient's blood to the perfusion pump for the surgeon complete the procedure quickly.At the end of the case, the perfusionist looked at the venous cannula and noted that it appeared that several of the drainage holes were not completely open from the manufacturing process.Cannula was saved, and the lot number noted.No apparent harm came to the patient and patient was transferred to the icu for recovery.Fda safety report id # (b)(4).

• Brand Name: VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SURGE CARDIOVASCULAR / MED MICHIGAN HOLDINGS LLC ; walker MI 49544
• MDR Report Key: 11737291
• MDR Text Key: 248152567
• Report Number: MW5101019
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: FEM-V1028
• Device Catalogue Number: FEM-V1028
• Device Lot Number: 03925-071520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 136