MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRES. OXY PACK - CAPIOX FX25E; CIRCUIT CONNECTORS

Model Number 75302

Device Problem Connection Problem (2900)

Patient Problem Blood Loss (2597)

Event Date 05/09/2016

Event Type  Injury  

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 during cardiopulmonary bypass, the arterial quick connects (distal to the oxygenator) came disconnected 3 to 4 minutes into the surgery.The perfusionist reconnected the quick connects.The patient required a transfusion of 2 units of blood.Blood loss of approximately 2 liters.Product was not changed out.Procedure completed successfully.

Manufacturer Narrative

The actual sample was returned for evaluation.The sample consisted of both the quick connects from the affected prescriptive oxygenator pack referenced in this report, and the quick connect from the custom tubing pack kit manufactured at a separate terumo facility, reported in mfr# 1212122-2016-00005.The parts were connected together when received and were attempted to be pulled apart by pulling on the bonded tubing in opposite directions.The components stayed connected during this attempt.Using the proper disconnection technique by pushing down on the thumb press of the body part, the parts disconnected with no issues.They were then reconnected and the proper clicking noise could be heard signifying a complete connection.This disconnection/reconnection test was repeated three times with no issues.The connection was then pressurized to approximately 550 mmhg and the parts were attempted to be pulled apart again while pressurized.Again, they stayed connected with no issues.No anomalies were noted from the appearance in the connection.The reported event could not be recreated and the event was not confirmed.The connection between the two quick connects is a customer-made connection during the setup of the circuit.It is likely that the quick connects had not been properly connected during the setup of the circuit, causing them to be disconnected during use.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: PRES. OXY PACK - CAPIOX FX25E
• Type of Device: CIRCUIT CONNECTORS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5684708
• MDR Text Key: 46072912
• Report Number: 1124841-2016-00220
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 75302
• Device Catalogue Number: N/A
• Device Lot Number: TN30
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other