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 Problem Blood Loss (2597)

Event Date 06/10/2019

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, the oxygenator failed to oxygenate blood loss 260ml.Product was changed out with 4 minutes delay.Procedure was completed successfully with 4 minutes delay.

Event Description

New information received that during coronary artery bypass (cabg), an arterial roller pump was used and they were off cpb for 24 seconds during the oxygenator change out.The act/heparin levels prior to and during cpb is greater than 480 and monitored via istat.The blood flow rate throughout cpb was 5.8 100% fio2, sweep 5.5lpm.

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.Upon further investigation of the reported event, the following information is new and/or changed: (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, 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.Visual inspection of the device did not find any obvious anomaly, such as a break, which could have been a trigger of the oxygenation failure.After having been rinsed and dried, the device was tested for its o2 transfer and co2 removal performance, with the obtained values meeting the factory specification.Bovine blood was circulated in the oxygenator module and no anomalies were revealed in the gas transfer performance of the actual sample.A root cause for the issue could not be identified.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: 8745742
• MDR Text Key: 149561569
• Report Number: 1124841-2019-00180
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: XC18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 08/15/2019
• Supplement Dates FDA Received: 07/15/2019; 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: I-STAT
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 139