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

Model Number 3CX*FX25RWC

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

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, oxygenator flow was reduced and high pressures were noted.This was discovered after 93 minutes on cpb.There was no pressure excursion noticed in the membrane and oxygenation function appeared normal.However flows were reduced through the device and high pressures were noted through digital palpation on the outflow of the device.There was a delay due to changing out the oxygenator.This necessitated removing the cross clamp from the aorta and coming off bypass.As the heart had not regained normal sinus rhythm the surgeon performed open cardiac massage while the perfusion team changed out the device.Approx.Time off cpb was 5-7 minutes to complete change out.Patient recovered normally in cvicu post-op.Product was changed out.Procedure was completed successfully.

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 february 24, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h3 (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 references conclusions code 11.) 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.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.The affected sample was inspected upon receipt to show no visual anomalies.The sample was then rinsed and dried and built into a circuit with tubing and conditioned bovine blood.The pressure drop at applicable flow rates were measured and the unit was confirmed to meet factory specifications.After pressure measurement were recorded, the unit was flushed with saline solution to confirm no clot formation was observed.A review of the manufacturing and incoming inspection confirmed no anomaly in the actual sample.A search of the complaint file found no other similar report with the involved product code/lot # combination.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received.Patient has no previous heparin exposure.The arterial pump was a roller pump.The patient's temperature at the time of the oxygenator change out was normothermic.The act values were monitored prior to and during cardiopulmonary bypass, 125/ 885(pre-cpb)/ 697(first on cpb)/ 494 (additional heparin given)/ oxy changed out/ >1000/ 103 (post-protamine).Additional heparin was given for act 494, follow up act was >1000.(we use istat act+ system).Patient has no known co-comorbidities.The patient did not require blood transfusion during this event.

• 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: 11375434
• MDR Text Key: 241305509
• Report Number: 1124841-2021-00026
• 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: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: YK10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention