MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP STERILE FX25RE OX W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RE

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Death (1802)

Event Date 08/31/2015

Event Type  Death  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete and/or more information becomes available.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

On (b)(6) 2015, a (b)(6) male patient received an avr with aortic repair and an mvr.This patient had a previous cardiac surgery in past years.The cpb circuit included a terumo system-1 with base s/n of (b)(4).The cpb circuit was terumo pack # b-8334txc-06 and contained a sarns centrifugal pump and a 3cx*fx25re oxygenator.Two cpb circuits and two different terumo system-1's needed to be used in the procedure.The lot # of the first cvr was te27, and the lot # of the second cvr was td09.According to the perfusionist, the patient had been on coumadin (warfarin), an anticoagulant, prior to surgery and had been discontinued a couple of days pre-op.According to the perfusionist, the patient demonstrated signs of hypercoagulability before cpb and thus a loading dose of heparin of 3.5 mg/kg (40,000 units) was given prior to the 1st pump run (an additional 10,000 units of heparin was in the prime solution).Prior to cpb, clotting was observed on the swan-ganz catheter during placement, and clotting was also seen in a blood collection bag (contained acd) as whole blood was collected from a central iv line prior to cpb (per their normal practice).According to the perfusionist, clotting is not usually observed during these maneuvers.There were no issues during the first cpb period.The pump time was about 2 hours and 50 minutes.There were no issues with gas transfer and no issues in the ability to produce the target blood flow rates.Rpm / flow relationships were within expected levels.After the initiation of cpb, the first act was 589 seconds and the heparin level was at target level of 3.5 mg/kg.The act gradually dropped during the first cpb period, and additional heparin was given as needed.In the last 45 minutes of cpb, the act ranged from 405 seconds to 465 seconds with additional 15,000 units of heparin given during this period.Again, no issues observed regarding gas transfer or blood flow.The patient was weaned from cpb, without issue and with adequate hemodynamics (blood pressure and ecg rhythm), and remaining volume in the cvr was transfused (the perfusionist estimated there was about 100 ml of blood in the reservoir).Per the perfusionist, it is standard perfusion practice to keep the sucker roller pump rotating after cpb for a period of time.When protamine is started, it is the responsibility of the surgical field staff to isolate and stop using the pump suckers and transition over to the cell saver sucker.After the patient was weaned from cpb, the perfusionist was doing some charting for approximately 3-4 minutes when it was announced the patient was bleeding (right atrial tear).The perfusionist looked down at the venous reservoir and noticed there was 4000 ml in the reservoir (when there was originally only 100 ml left at end of cpb).It appeared the pump suckers were being used, and protamine may have been started.The perfusionist stated he did not hear the command to start the protamine, but that the possibility could not be ruled out.The cv surgeon ordered the anesthesiologist to give a re-loading dose of heparin in preparation for cannulation and emergent return to cpb.The initiation of cpb was attempted at about 7 minutes after the initial weaning of cpb, but the perfusionist was not able to generate arterial blood flow in spite of pump speeds of about 2000 rpm.Clots were seen in the oxygenator / reservoir, and initially the plan was to change out the oxygenator / cvr only.After additional considerations, the clinical team elected to bring in a completely new cpb circuit that was set-up and used on a different terumo system-1 hlm.This required set-up and priming, and the re-initiation of cpb was delayed about 20 minutes.The 4000 ml of blood that remained in the original cpb circuit was not able to be transferred and used in the second circuit; therefore, blood loss is estimated to be about 4000 ml.The second cpb period was without observed issues, and there were no issues with gas transfer and / or arterial flow rates.The patient was weaned from cpb successfully, but an iabp was placed to augment coronary and cerebral blood flow post cpb.Acts remained at >750 seconds the second cpb period.When the cpb circuit was drained post cpb, clots were seen at the base of the second cvr.The terumo system-1 unit was inspected and tested by terumo fsr the following day.According to the fsr, a full pm inspection was completed and the system-1 operates to terumo specs.The logs were collected and analyzed by terumo technical support.This hlm system has been used at (b)(6) since this event.Per meeting with the perfusionist and the risk manager on (b)(4) 2015, it was discovered the patient expired on (b)(6) 2015 at 3:24 pm.The case was completed, as scheduled, but there was about a 20 minute delay in the procedure and in the re-initiation of cpb.Blood loss was estimated at about 4000 ml.There is no information gathered from system-1 inspection, log analysis, oxygenator and pump functions during the first cpb period (almost 3 hours) that illustrates functional issues with the system or cpb circuit components.

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 september 15, 2015.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (indication that the device was not returned to manufacturer), (identification of evaluation codes: 12, 38, 3304, 37, 213, 92).The actual device was not returned for inspection; however, photographs provided by the user facility of the actual device during use were reviewed.The photographs indicated thrombus had adhered to the lower area of the venous reservoir contributing to the reported complaint.Since the actual device was not returned, the investigation was limited to the visual inspection of a retention sample produced around the same time as the actual device and the review of the device history record.Both confirmed there were no anomalies that would contribute to the reported complaint.Without the receipt of the actual device, the root cause could not be determined.The device labeling addresses the potential for such an occurence in the instructions-for-use by statements such as, "adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur." all available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The actual device was not returned for evaluation; therefore, a retention sample from the same product code and lot number was obtained for testing.The retention sample was visually inspected and no anomalies were noted.Following the reservoir clot test, the sample was built into a circuit and bovine blood was circulated through the reservoir and oxygenator for one hour.At the end of the hour, the sample was drained and rinsed with deionized water.The sample was then visually inspected and no clotting was noted within the cr filter.There were also no flow issues noted during the test.A review of the device history record revealed there were no anomalies.A definitive root cause could not be determined; therefore, this complaint could not be confirmed.It is likely that the patient's blood conditions and/or perfusionist management of act was the cause of the reported complaint.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

• Brand Name: STERILE FX25RE OX W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5078634
• MDR Text Key: 25851649
• Report Number: 1124841-2015-00253
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/10/2015,10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2018
• Device Model Number: 3CX*FX25RE
• Device Lot Number: TD09
• Other Device ID Number: (01)00699753450462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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: 63 YR