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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

(b)(4) inc.Catsmart continuous autotransfusion system failed at the beginning of the 3rd quarter.

• Brand Name: CATSMART
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI AG; 3 corporate drive; lake zurich IL 60047
• MDR Report Key: 10747541
• MDR Text Key: 213436927
• Report Number: 10747541
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Date Report to Manufacturer: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1