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

Model Number 3CX*FX25RWC

Device Problems Leak/Splash (1354); Filtration Problem (2941)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 08/05/2020

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 after cardiopulmonary bypass, clots were found in the cardiotomy reservoir and as a result, approximately 100-150 ml blood came out of the reservoir and was on the floor.The pump was left on standby in the low flow circulating condition with 999 sec act.After 90 minutes, they found clots in the cardiotomy.They did not use a level alarm.Blood loss approximately 100-150ml.Procedure completed successfully.

Event Description

Additional information received, as per the clinical specialist, the facility have faced this issue 4-5 times in the past with different perfusionists, and all were post bypass irrespective of bypass duration.The user facility mentioned different situation where in after 60 minutes of bypass, they need to go on bypass with the same circuit and found multiple clots in the reservoir and oxygenator.They also mentioned that, when the bypass is off and patient was shifted to icu, they left pump on the circulating circuit (>500 act) with the reservoir level of 400ml in the or and once they came back they found reservoir empty and all the volume collected in the cardiotomy reservoir.To clarify, they tried the add the volume but all the volume collected in the cardiotomy reservoir and at one point it started coming out through side cardiotomy ¼ port.Lastly, they kept the pump on the circulation through recirculation line connected to cardiotomy reservoir with 672 act.Initially reservoir volume was 500 ml but after 10 minutes the volume left was only 200ml; the volume holdup was high.To manage this situation, they put the circuit on the main reservoir with 5 lpm flow and slowly this situation improves.As per the hospital protocol, they immediately stop the suckers once the protamine starts.As a routine, the hospital keeps the circuit post bypass for at least 60 minutes for any emergency situation.They keep this circuit in the running condition through recirculation line which is connected to the cardiotomy reservoir and maintain 0.5 to 1.0 lpm flow with > 500 act.

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 13, 2020.The actual sample was not returned for evaluation.A representative retention sample from the same lot number was obtained and no visual anomalies noted.It was then tested for clotting with bovine blood (hct 35.5%, be -1.2 and 37*c) at 5 l/minute for one hour with 100ml/min air injection with no clotting, foaming or bubbling on the filter observed in the cardiotomy portion of the reservoir.After completing standard protocol testing, blood conditions were modified in an attempt to recreate the conditions observed by the customer.Hct was reduced to 10.3% and blood flow was reduced to 0.4 lpm.Blood flow was maintained for two hours under these conditions.In total, blood was flowing through the cardiotomy filter for 4 hours and 40 minutes and no clotting or flow restrictions were observed.Without a returned device a thorough investigation could not be performed and a definitive root cause could not be determined.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
• MDR Report Key: 10455644
• MDR Text Key: 204419949
• Report Number: 1124841-2020-00202
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XL23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 78