MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Death (1802)

Event Date 07/24/2017

Event Type  Death  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, clot was seen in the reservoir.The information provided during the clinical review indicates that the clot in the reservoir formed after cpb.It also states that the patient could not maintain circulation and expired on the operating room table.This case was an emergency re-do surgery.The patient associated with this complaint was previously exposed to heparin prior to this aortic root abscess procedure.The patient had an aortic dissection and bentall procedure in 2012 and had a stent procedure in the cath lab for a myocardial infarction.It was also noted that the patient was an intravenous drug user.According to the clinician no protamine was given but it's likely that bio-glue was used on the aorta.The patient was on bypass for >6 hours.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 11, 2017.(b)(4).Visual inspection of the returned reservoir sample found clots present in the cardiotomy filter.The reservoir clotting test was performed on the reservoir sample, which included circulating bovine blood through the unit for one hour at a high flow rate.During visual inspection, it was found that no additional clots had formed within the filters of the reservoir, other than the dried clots from when the sample had been returned from the customer.Upon evaluation of the returned sample, it was confirmed that clots were present within the reservoir prior to decontamination.It was found to function as intended, without forming any additional clots or experiencing any flow anomalies.The reported event was unable to be replicated; therefore, a definitive root cause was not able to be determined.It is likely that patient conditions contributed to the formations of clots within the reservoir filter.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6787911
• MDR Text Key: 82479362
• Report Number: 1124841-2017-00175
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UE11
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Weight: 116