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

Model Number 3CX*FX25RWC

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 12/03/2019

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 arterial line manifold sampling of the oxygenator did not work.There was reported patient injury but now in good condition.The customer did not specify the injury and terumo cardiovascular continues attempt to obtain more information.The product was changed out.Procedure 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 december 27, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4: (additional device information: added expiration date).G4: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to additional information).H4: (device manufacture date).H6: (identification of evaluation codes 11, 3331, 4114, 3221, 4315).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 - 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned so a thorough investigation was not able to be conducted.The manifold from a representative retention sample was reviewed and tested to ensure it worked appropriately.The retention sample was setup into a water circuit with water flow through the manifold assembly.The stopcocks were operated and functioned as expected and water flowed through the assembly as expected.Due to the details provided with this complaint, it is not possible to determine a root cause for this event.It's most likely that the manifold assembly was damaged at some point in handling, however, when or how it was damaged is not able to be determined with the provided information.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, 170, 25).Method code: 10 - testing of actual/suspected device.Results code: 170 - manufacturing process problem identified.Conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt with no visual anomalies noted.Water was able to pass through the affected line.Initially, water flowed slowly them stopped.Disassembly of the line found that excessive bonding agent was in the connector.The manifold from a representative retention sample was reviewed and tested to ensure it worked appropriately.The retention sample was setup into a water circuit with water flow through the manifold assembly.The stopcocks were operated and functioned as expected and water flowed through the assembly as expected.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: 9525669
• MDR Text Key: 173304619
• Report Number: 1124841-2019-00347
• 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,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XM07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other