MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR TERUMO CARDIOVASCULAR; MULTI PERFUSION ADAPTER

Model Number PERFUSION SET

Device Problem Partial Blockage (1065)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Occlusion within tubing bond joint of the multi-perfusion adapter preventing flow during aortic valve replacement (avr) procedure.

• Brand Name: TERUMO CARDIOVASCULAR
• Type of Device: MULTI PERFUSION ADAPTER
• Manufacturer (Section D): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer (Section G): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial drive ne; grand rapids, MI 49505 ; 6168211323
• MDR Report Key: 16630802
• MDR Text Key: 312168293
• Report Number: 3017540705-2022-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: PERFUSION SET
• Device Catalogue Number: 824367
• Device Lot Number: 03418-121319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention