MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Death (1802)

Event Date 09/20/2018

Event Type  Death  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.For this reason, terumo references evaluation conclusion code.(b)(4).Results: results pending completion of investigation.Conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a presence of white and red clot was seen in the arterial filter of the oxygenator.The procedure was a aortic valve replacement and cab x 1 to right coronary artery.Heparinization: 40,000 u loading dose, 10,000 u in pump prime.Pre-bypass act was 550 seconds.Serial acts: 1st on bypass, 764 secs, then in succession with no times noted, 616, 634 and 493 seconds.An additional 10,000 u heparin given in response to the 493 seconds.The resultant act was 666 seconds.The total pump time was 1 hour and 49 minutes, with the cross clamp time being 1 hour and 34 minutes.The lowest temperature on bypass was 34.4 degrees c.The patient received tranexamic acid per routine.Prior to the termination of cardiopulmonary bypass the patient¿s hematocrit was increased from 31% to 36% by the use of a hemoconcentration.1000ml of effluent was removed from the patient¿s circulating blood volume.With the embolic concerns regarding the finding of clot formation in the oxygenator, an initial ct scan was performed early during the icu stay that showed potential changes in the hypothalamus.The patient was unconscious and hemiplegic, a follow up ct scan was performed and revealed multiple emboli in the brain.This scan was performed 3 days post operative.The lipid profile, coagulation studies performed post operative showed no abnormalities.Upon entry to the icu, the troponin level was 205, and elevated to 900 the next morning.The patient passed away 3 days post operative.Product was changed out.

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 (b)(6) 2018.Upon further investigation of the reported event, the following information is new and/or changed: (describe event or problem - corrected information on changed out); (device availability - added date returned to manufacturer); (date application evaluated by manufacturer;) (indication that this is a follow-up report); (follow-up due to correction and additional information) ; (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

The product was not changed out.

Manufacturer Narrative

Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added exp date); (date received by manufacturer); (indication that this is a follow-up report); (follow-up due to additional information and device evaluation); (device evaluated by manufacturer); (device manufacture date); (identification of evaluation codes (b)(4)).The actual sample was returned for evaluation, and some clots were noted to have formed on the surface of the sample.It was visually inspected upon receipt and found that the purge line had been cut off.No other anomalies noted on the device.The actual sample was rinsed and dried.It was subsequently built into a circuit with tubes.Bovine blood was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the factory's specification, and no obstruction was confirmed.After the pressure test, bovine blood was kept circulated in the circuit for 6 hours with no obstruction.When the circulation was ceased, it was flushed with water, and no clot was found inside the sample.Review of the device history record and the product release control sheet of the involved product/lot number combination confirmed that, there were no indication of production-related anomalies.The evaluation of the actual sample after having been rinsed was the normal product presenting no issue relating to the confirmation of clots; therefore, the cause of this complaint cannot be determined definitely.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7957413
• MDR Text Key: 123481847
• Report Number: 1124841-2018-00259
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• 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,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: WH30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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: 67 YR
• Patient Weight: 100