MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Use of Device Problem (1670)

Patient Problems Aortic Dissection (2491); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

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, low oxygenation occurred.As per user facility, during the circulatory arrest, (aortic dissection circulatory arrest, hypothermia at 25°c, total duration 263.33mn, aortic clamping 166.29, assistance only 94.53 cerebroplegia 92.24) no oxygenation or decarboxylation problems, the blood gases were correct, flow rate at 1.5l for 20-30 minutes, then in front of a slightly lowered nirs (near infrared spectroscopy), increase the flow rate to 1.7l until the end of the circulatory arrest.The surgeon then advised to resume the flow, signing the end of the circulatory arrest, so the fio2 was set at 100% on the sechrist, increased the sweep and requested act which was greater than 400.The flow was resumed for over a few minutes.It was observed on the cdi that the parameters are panicking: the pao² decreases despite the fio² to 100% and the pco² rises but remains "reasonable", then the anesthesiologists put 100% fio² on the ventilator.In a few seconds: we move on to galloping hypercapnia still the pao2 decreases inversely with pco2.The sweeping on the sechrist was increase to 10 or 12 l.Cardioplegia was done, then the blood in all the tubing is black, pao² goes down to about 50mmhg on the cdi, pco² is 110mmhg.The parameters on the sechrist was kept at maximum fio² 100% and scan 12.Cec was changed with no problem on it.However, while they debubbled the 2nd cec it still has no improvements on the gases on the cdi.Results correlated by the blood gases that were done very closely as soon as they started to no longer properly oxygenate the patient.The product was changed out.It is unknown if there was a blood loss.It is unknown if there was a delay and 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: d4 (additional device information - added exp 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, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The actual sample was received and was visually inspected upon receipt with no obvious anomalies such as break in the appearance.After having been rinsed and dried, the actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.The investigation result verified that the actual sample, after having been rinsed, was the normal product with no issue in the gas transfer performance.From the available information, the possibilities can be inferred; however, it is difficult to determine the definitive root cause.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 february 27, 2019.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 4114, 3221, 4315).Method code: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The actual sample was not returned for investigation and lot number was not provided.Multiple attempts were made to obtain additional information.Without further information, it is not possible to determine a definitive root cause.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: h3 (device evaluation anticipated by manufacturer - a third 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 FX25REC 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: 8373453
• MDR Text Key: 139187443
• Report Number: 1124841-2019-00056
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECHRIST
• Patient Outcome(s): Required Intervention