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

Model Number 74283

Device Problem Disconnection (1171)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 11/01/2017

Event Type  Injury  

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 november 17, 2017. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

The returned sample was visually inspected. Nothing was noted on the device other than dried blood from the reported disconnect. Sample was connected to a manometer and pressurized with water up to 500 mmhg (clinically relevant pressure) and inspected for any signs of leaks. The line was manually put under repeat tension and manipulated to determine if the line would disconnect. The unit did not disconnect. Based on the results, the most likely cause of the reported disconnect was due to either the line not being fully connected or something had depressed the lever for disconnecting the quick connect. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 quick connect on the outlet of the oxygenator came apart. It was separated while warming on the circuit arrest case. There was zero activity at the field and zero change in flow or pressure. The patient was given 3 units of blood. There was a blood loss of 800 ml. There was a delay for 30-60 seconds. Product was not changed out. Procedure was completed successfully.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7042257
• MDR Text Key: 249629837
• Report Number: 1124841-2017-00239
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Model Number: 74283
• Device Catalogue Number: N/A
• Device Lot Number: VK14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/17/2017 Patient Sequence Number: 1