MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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 prior to cardiopulmonary bypass, during setup, the line on the outlet of the oxygenator blew off, even if it was tie banded and past the first barb.  no patient involvement, 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.Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added exp date).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information and device evaluation).(device evaluated by manufacturer).(device manufacture date).(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 returned; however, the actual tube sample in this complaint was not provided for evaluation.Visual inspection upon receipt found that the purge line tube has been cut off the main body and no other anomalies noted.The visual and magnifying inspections of blood outlet port also did not reveal any anomaly including deformity, and the outside diameter of the blood outlet was also measured and verified to meet the specifications.A factory-retained tube of the applicable size was connected to the blood outlet port and fixed to the port with a tie-band.It was circulated with a saline solution with a roller pump at a flow rate of 5l/min for 30 minutes, and the tube did not came off the port.The tie band was then removed and circulation was continued for another 30 minutes, coming off the tube was not duplicated.Review of the device history record and the product release decision control sheet of the involved product/lot number confirmed.That there were no indications of product related anomalies.The investigation result verified that the blood outlet port of the actual sample was normal with no generation of deformity on it.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 may 04, 2017.  upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).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.

Event Description

Additional information was received indicating that the issue occur when they were flowing about 4-5l of prime solution, it came off after about 30 minutes.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8340779
• MDR Text Key: 136319316
• Report Number: 1124841-2019-00043
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: WN26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1