MAUDE Adverse Event Report: FRESENIUS KABI, LLC. FRESENIUS CATS AUT; APPARATUS, AUTOTRANSFUSION

Device Problems Obstruction of Flow (2423); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/15/2016

Event Type  malfunction  

Event Description

The cell saver was being used on a very sick transplant patient with a large estimated blood loss.We were utilizing the fresenius cell saver to make sure we provided the blood back to the patient.The tech running the machine noticed the holding bag was not emptying appropriately.At first we changed the pall filter, but that did not work.They then spiked the other port of the holding bag and that resolved the issue.When the bag was empty they noticed a large clot that had stopped the flow of blood.This required us to break down the entire set up and redo it, wasting patient's blood and taking time out in a critical case.The clot should be washed out during the washing process and the machine did not alarm until after it was broken down.This is unacceptable.We are not going to use the product until the vendor comes up with a solution.Manufacturer response for cell saver, (brand not provided) (per site reporter): they mentioned that he has seen this before (rarely) when not enough anti-coagulant was used.Their recommendation was to always agitate the blood in the reservoir making sure it stays mixed to prevent clots.When the reservoir is empty make sure you flush another round of heparin solution which was done during the case.The operating room staff do not believe lack of heparin solution was the issue.In this situation we were on bag #2 of heparin saline solution when incident took place.Machine was set in emergency mode and continuously processing blood.

• Brand Name: FRESENIUS CATS AUT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESENIUS KABI, LLC.; cheryl roscher; three corporate drive; lake zurich IL 60047
• MDR Report Key: 5996285
• MDR Text Key: 56368214
• Report Number: 5996285
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: WASH KIT LOT ELT065
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2016
• 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, HEPARIN BOLUSES
• Patient Age: 60 YR