MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

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 it is impossible to anchor different types of three-way valves.The threading on the male luer with short and / or nonrotatable ring, is impossible to anchor on the cardiotomy and was mitigated by using a stopcock on the luer.No known impact or consequence to patient.Product was changed out.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: h6 (identification of evaluation codes 10, 11, 3331, 180, 22).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: 180 - mechanical problem identified, conclusions code: 22 - known inherent risk of device.The returned samples were visually inspected and it was confirmed that the luers were sufficiently inserted into the reservoir ports, however, the customer supplied samples continued to spin about the threads without ever locking around them.The luered ports on the reservoir lid are checked in process for the internal sealing taper, using a calibrated luer gauge.However, there are luer ports on the reservoir that only have half threads.The connectors supplied by the customer do not lock on these ports.The luer ports were not designed with full threads.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 april 18, 2019.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction).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 that the product was changed out.

• 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: 8528885
• MDR Text Key: 142408247
• Report Number: 1124841-2019-00099
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: WN12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1