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

Model Number 3CX*FX25RWC

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

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, there was a differential between the venous temperature and the swan-ganz.No consequences or impact to the patient.Product was not changed out.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 may 22, 2019.  upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 213, 67).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer, method code #2: 3331 - analysis of production records, method code #3: 4114 - device not returned, results code: 213 - no device problem found, conclusions code: 67 - no problem detected.The sample was not returned for evaluation.Two returned samples for a similar complaint were used for the investigation.A terumo corporation (japan) fx15 oxygenator/reservoir sample was obtained as well as a tcvs representative retention sample.No anomalies were noted with any of the units.The four samples were set up in a series and water was circulated through the units.Temperatures were taken from each of the samples at room temperature, warm temperature, and a cooled down temperature, once steady state was achieved at each level.There were no temperature differences between any of the samples at any water condition.The venous inlet ports were then cut out to measure the relative depth of the installed thermistor.Evaluation of the returned samples compared against the retention samples found that there was no difference between the temperature readings.The reported event was not able to be replicated and the complaint was not confirmed.It is known that there can be variability in the depth that the thermistor reaches within the oxygenator port, this variability exists in both the elkton manufactured oxgyenators as well as the tc manufactured oxygenators.In addition, if temperatures are taken at two separate locations and then compared, the variability in the fluid may cause the temperatures to truly be different at these different locations.If temperatures are read at a time that the fluid is being warmed or cooled, and a steady state temperature is not achieved prior to measuring this temperature, this will also cause a difference in readings.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: 8634791
• MDR Text Key: 145915762
• Report Number: 1124841-2019-00149
• 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
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XC11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SORIN S5; SORIN S5