MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRESCRIPTIVE OXY PACK - CAPIOX; BLOOD GAS OXYGENATOR

Model Number 74283

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/22/2019

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, a leak was noted where the tie band connects the quick connect.There was a blood loss of 2-5 ml.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 september 10, 2019.Upon further investigation of the reported event, the following information is new and/or changed: identification of evaluation codes 3331, 4114, 4210, 4315.Method code #1: 3331 - analysis of production records.Method code #2: 4114 - device not returned.Results code: 4210 - leakage/seal.Conclusions code: 4315 - cause not established.The affected sample was not returned, so a thorough investigation was not able to be conducted.Pictures provided with the complaint were reviewed in the investigation.Retention samples are not kept for this product code.The most likely cause of this complaint is the connection in the tubing with the user made connection between the oxygenator and the rest of the bypass circuit.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8983992
• MDR Text Key: 158657268
• Report Number: 1124841-2019-00253
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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: 10/03/2019

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: 04/30/2021
• Device Model Number: 74283
• Device Catalogue Number: N/A
• Device Lot Number: XF06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1