MAUDE Adverse Event Report: FRESENIUS KABI AG C.A.T.S; APPARATUS, AUTOTRANSFUSION

Model Number 9005081

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/09/2016

Event Type  malfunction  

Event Description

We used the cats plus autotransfusion device on a right periacetabular osteotomy.The device functioned fine during the case; it ran without any errors for the whole case.Towards the end of the case we spun the cellsaver and ran the appropriate qc's to ensure the device was functioning properly.The pre hct was 23.0 the post hct was 12.4, at which time i called our rep for the device.She instructed me to make sure the camera in the machine and the light source were clean and free of any debris.I cleaned the camera and light source we put the blood back into the reservoir as instructed by the rep, to rerun the blood.After the second run the pre was 19.6 post was 37.5, which is still unacceptable.Again i called the rep she instructed me to change out the disposable, which we did and the end results was an hct of 34.1.This is still under the acceptable range of >40%, we did not return any of the spun product to the patient and the device #(b)(4) was taken out of service.Manufacturer response for fresenius cats cell saver, cats (per site reporter): the manufacturer has been contacted and they are sending a service personnel to look at the machine.See previous information.Other disposable items lot numbers: wash kit fbt 092 a&a line fat 211 reservoir fbt 093.

• Brand Name: C.A.T.S
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI AG; three corporate drive; lake zurich IL 60047
• MDR Report Key: 6221545
• MDR Text Key: 63846651
• Report Number: 6221545
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9005081
• Device Catalogue Number: 9005081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• 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
• Treatment: OTHER DISPOSABLE ITEMS LOT NUMBERS:WASH KIT FB