MAUDE Adverse Event Report: FRESENIUS KABI AG AT3 AUTOTRANSFUSION SET; APPARATUS, AUTOTRANSFUSION

Model Number 9005444

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

Fresenius c.A.T.S.Cell saver disposable had a malfunction during open heart case causing shed blood from surgical field to not be washed appropriately.The shed blood went directly to wasted bag vs.Being properly washed for infusion.

• Brand Name: AT3 AUTOTRANSFUSION SET
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI AG; 3 corporate drive; lake zurich IL 60047
• MDR Report Key: 13513622
• MDR Text Key: 285472906
• Report Number: 13513622
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9005444
• Device Catalogue Number: 9005444
• Device Lot Number: LHA251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Race: White