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

Model Number CATS

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 01/20/2018

Event Type  malfunction  

Event Description

The fresenius continuous auto transfusion system (cats) was ready for use but idle when it made a popping sound and emitted a plume of smoke during an exploratory laparotomy case.The machine also had the distinctive odor of an electrical fire, but no flames were seen.The machine was immediately unplugged and removed from the operating room.It was later received for testing by our htm (biomed) department.A replacement machine was obtained for the operating room.There were no consequences to the patient beyond a brief delay of the procedure.Manufacturer response for continuous auto transfusion system, cats (per site reporter).Manufacturer's response is pending their field agent's inspection of the device.

• Brand Name: CATSMART SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI WARRENDALE; 770 commonwealth dr; warrendale PA 15086
• MDR Report Key: 7214890
• MDR Text Key: 98065125
• Report Number: 7214890
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CATS
• Other Device ID Number: BMI# M021132
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2018
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1