MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2019

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 non-clinical activity, there was crack found on top of the reservoirs.No patient involvement as this occurred during non-clinical activity.

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 february 8, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was not returned for evaluation nor were any pictures provided, therefore a thorough investigation could not be performed and definitive root cause can not be determined for this event.A representative retention sample from the same lot number was inspected and no damage was found to the reservoir.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the reservoir and its components during shipping.It is likely that the reservoir 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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8320170
• MDR Text Key: 135519129
• Report Number: 1124841-2019-00033
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: 09/30/2021
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: WM15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1