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

Model Number 3CX*FX25RWC

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/19/2019

Event Type  malfunction  

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, the oxygenator leaked.There was an accumulation of blood in the lower part of the oxygenator and drops had fallen on a sponge which was changed several times.The patient had abnormally high plasma hb which resulted in red urine.There was 20ml of blood loss.The product was changed out.The 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 december 6, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).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: d4 (additional device information - added expiration date); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information and device evaluation); h3 (device evaluated by manufacturer); h4 (device manufacture date); h6 (identification of evaluation codes 10,11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The actual sample was visually inspected upon receipt, and no anomaly such as break that could lead to leakage on the blood inlet port or the oxygenator housing was found.The tubing had been inserted about 13mm over the blood inlet port was insufficient insertion depth.The end of tubing had not reached the second barb.No blood had been adhered to the joint section of the blood inlet port.The actual sample was rinsed and removed from the tubes.The blood channel was filled with saline solution and was pressurized to 2kgf/cm2 was applied and no leak was observed.The actual sample was then built into circuit with tubes.To the blood inlet port, a tube was joined by a 13mm that was inserted over the port.The circuit was filled with colored saline solution, while the saline solution was circulated at 3000rpm, the tube attached to the blood inlet was pulled upward and the gap was made between the tube and the leak occurred.When the tube was free from being free from being exposed to such pulling force, the gap disappeared and the leak stopped.The investigation verified that the actual sample had no issue related to leakage, however a video was provided with the complaint confirming the leak.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: b1 (patient information - added patient weight); g4 (date received by manufacturer) ; g7 (indication that this is a follow-up report) ; h2 (follow-up due to additional information).An additional 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.

• 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: 9433190
• MDR Text Key: 200880342
• Report Number: 1124841-2019-00328
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XM07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 82