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

Model Number 3CX*FX25RWC

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Cardiac Arrest (1762); Injury (2348); Blood Loss (2597)

Event Date 07/24/2018

Event Type  Injury  

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, air bubbles were noticed at the hard shell reservoir outlet.As they attempted to refill the patient by the cardioplegia circuit, unpriming of the oxygenator, the patient received an air bubble into the aorta.The arterial pump was put on stand alone mode, filled the patient and restarted the ecc.The user facility identified the issue at the venous hardshell outlet (as the tie band rotated instead of being well tightened).A tie band was added on the outlet connector and the procedure was complete.The patient had cardiac arrest then convulsions few hours after the operation.The patient had woken up and was oriented but with hemiplegia.Blood loss amount is unknown, 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 august 21, 2018.(b)(4).The returned sample was inspected and set into a circuit and flowed at approximately 5 l/min, the sample did not show any tendency for air bubbles to reach the patient, which is to be expected as the additional complaint details explain that the issue was fixed during the case.The tube connected to the reservoir outlet port was noted to be extremely loose and the tie band was not cinched enough to properly hold the connection at the reservoir outlet port.The tubing was easily shifted up and down the reservoir outlet port.As the tubing was shifted lower off the port, air was noticed to be sucked into the circuit, confirming the complaint.The root cause of this issue is a poor connection between the tubing and the reservoir outlet port, including a tie band not properly fixed onto the tubing.This connection is made by the terumo tubing pack manufacturer.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: 7800685
• MDR Text Key: 117704478
• Report Number: 1124841-2018-00185
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: VP18 OR WA01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUBINGPACK (2CXFR265X); TUBINGPACK(2CXFR265X)
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 75