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

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Type  Injury  

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, specifically towards the end, there were white clots noted distal to the arterial filter within the oxygenator of the bypass machine.Per user facility even though patient's oxygenation and map remained stable throughout the surgery, he was slow to awaken postoperatively and it was felt he may have had an embolic stroke.Later testing indicated an embolic stroke, with micro embolism versus a major clot, along with increased swelling and a mass effect.It is unknown if the product was changed out, if there was delay in the procedure, nor if the procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 11, 4114, 3331, 114, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 50-adverse event related to patient condition the affected sample was not returned for evaluation, however, the pictures that were provided were reviewed and confirmed the reported event.Review of device history records and product release decision control sheet of the involve product and lot number combination confirmed there was no indication of production-related anomaly or of nonconforming inspection results.Information provided by the medical facility indicated that the patients platelet count was higher than normal which could have led to the formation of a white clot in the oxygenator.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 in the initial report submitted to the fda on march 12, 2019.A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information was obtained regarding this event.There was no delay in the procedure, the product was not changed out, and the surgery was completed successfully without patient blood loss.The patient went to the er experiencing cardiac arrest, was taken to the cardiac cath lab, had an impeller inserted for cardiac support which was removed a couple days later.The patient had cabg x 2 on cpb.The patient's platelet count kept significantly increasing the few days prior to surgery with the platelet count being 609,000 the morning of surgery.The act value after initial heparinization was 383 seconds.No additional heparin was given by anesthesia prior to cpb because there was 10,000 units of heparin in the pump prime.The first act on cpb was 507 seconds and the next act on cpb was 438 seconds for which another 10,000 units of heparin was given and the subsequent act was 507 seconds.Biologic material inside the oxygenator housing was noted at the end of cpb.The patient was cooled to 32.7 degrees centigrade with the bypass time of 133 minutes and with arterial pump as a roller pump.There was no increase in line pressure during cpb.

• 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
• MDR Report Key: 8414576
• MDR Text Key: 138637015
• Report Number: 1124841-2019-00071
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: WN19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/14/2019; 04/22/2019
• Supplement Dates FDA Received: 04/02/2019; 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR