MAUDE Adverse Event Report: 3T MEDICAL SYSTEMS, INC. CBCII CONSTAVAC; APPARATUS, AUTOTRANSFUSION

Model Number 225-028-000E

Device Problem Misconnection (1399)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

Cbc ii constavac blood conservation system opened to and found to have drain connected to the canister instead of the extension tubing.Second system opened which was found to be connected correctly.

• Brand Name: CBCII CONSTAVAC
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): 3T MEDICAL SYSTEMS, INC.; 41157 capital drive; canton MI 48187
• MDR Report Key: 10689638
• MDR Text Key: 211665845
• Report Number: 10689638
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2020,09/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 225-028-000E
• Device Catalogue Number: 225-028-000E
• Device Lot Number: 19071201M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA