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

Model Number	9005444
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Fresenius continuous autotransfusion system (cats) unit stopped working at beginning of use, was not able to finish a cycle.After initiating use, the unit displayed a "blood in" and "blood flow" error.Unit was removed from service and brought to clinical engineering for inspection.Manufacturer was called in and after troubleshooting the unit found a problem with the at3 autotransfusion set.The manufacturer's engineer found the set tubing that goes to the htc sensor not long enough (a possible manufacturing error) to allow the sensor to reach its proper placement in the cat unit, having the user to pull on the tubing in order to make it reach.While the user pulled on the tubing, inadvertently decreased the tubing internal size, preventing the blood to flow through it, thus causing the system error and stopping operation.The at3 part number is (b)(4) and the lot number is fit 063.A new at3 from a different lot was used to test the cat unit and the system worked fine, according to manufacturer's specifications.Manufacturer response for at3 continuous autotransfusion set, at3 autotrasfusion set (per site reporter).Manufacturer field engineer checked unit and concluded problem was caused by the at3 set (lot # fit 063) not being manufactured correctly.

• Brand Name: AT3 AUTOTRANSFUSION SET
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI AG; three corporate drive 2nd floor; lake zurich IL 60047
• MDR Report Key: 7501883
• Report Number: 7501883
• Device Sequence Number: 10807016
• Product Code: CAC
• UDI-Device Identifier: 04052682000867
• UDI-Public: (01)04052682000867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2018
• Report Date (Section F): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Unknown
• Device Expiration Date: 08/06/2019
• Device Model Number: 9005444
• Device Catalogue Number: 9005444
• Device Lot Number: FIT 063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT KNOWN AT THE MOMENT.
• Date Report Sent to FDA: 05/07/2018