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

Model Number 3CX*FX25RWC

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

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 prime, a crack was noticed on the tubing from the sampling manifold causing it to leak.No patient involvement.Product was 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 20, 2019.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes (10, 11, 3331, 3259, 4307).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 #2: 3331- analysis of production records, results code: 3259 - improper physical structure, conclusions code: 4307 - cause traced to component failure.The returned sample was visually inspected, confirmed the cracked connector along the l-shaped connector.A retention sample was visually inspected and confirmed to not have any damages or cracks on the l-shaped connector.It is likely that the manifold connector was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.During the investigations of similar events, replication testing found that this crack appears on the part when the l connector is over tightened on a port.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: 8625040
• MDR Text Key: 145543692
• Report Number: 1124841-2019-00133
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: WL17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1