MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 06/18/2019

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 partial pressure of oxygen (po2) started dropping and partial pressure of carbon dioxide (pco2) started rising.Product was changed out.Blood loss of 150 ml.It is unknown if the surgery was completed successfully.

Event Description

Based on all available information, it was determine that the issue reported under mfr# 1124841-2019-00190 is duplicate of mfr# 1124841-2019-00186.Further investigation will be reported under mfr# 1124841-2019-00186.

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: 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.

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: 3221 - no findings available.Conclusions code: 67 - no problem detected.The actual sample was visually inspected upon receipt and did not find any anomaly.After having been rinsed, 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.Review of device history record and product release decision control sheet of the involved product/lot number combination confirmed that there were no indications of anomalies in them.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, 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.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8773600
• MDR Text Key: 150481762
• Report Number: 1124841-2019-00186
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• 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: 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: 02/28/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XD18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 07/22/2019; 08/15/2019
• Supplement Dates FDA Received: 07/16/2019; 08/13/2019; 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLE MOUNT BLENDER. OXYGEN TANK.; GEM.; POLE MOUNT BLENDEROXYGEN TANK
• Patient Outcome(s): Other