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

Model Number 3CX*FX25RWC

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 06/27/2017

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.For this reason, terumo references evaluation conclusion code.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a tie banded line from the bottom of the reservoir going to the livanova revolution centrifugal inlet was dislodged.With significant blood loss; product was not changed out; procedure was completed successfully.The venous line from the outlet of a terumo reservoir disconnected by itself while already on bypass and was cross clamped.Centrifugal pump and tubing were sorin.Everything was pushed pass second barb and tie banded.Blood was lost and required one unit of rbc.The same line was connected back to the reservoir followed by quick re-prime and going back on bypass, nothing was changed.The customer stated that there was significant blood loss but there was no volume of blood loss provided.According to the information provided, the patient was fine.The tubing connected between the reservoir outlet and centrifugal pump inlet was coated with sorin biopassive surface coating.

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 jul 23, 2017.(b)(4).The sample was not returned for evaluation, therefore, the complaint was not confirmed and a definitive root cause was not able to be determined.A retention sample from the same product code and lot number combination was obtained.The dimensions of the first two barbs on the reservoir's blood outlet port of the retention sample were measured using calipers.The first barb was found to measure within the specification and the second barb measured within the specification.Dimensional measurements of the retention sample confirmed the blood outlet port to be within specification.During the molding process of the reservoir, a sample size of parts are measured by the cmm to ensure the product is within specification.As the tubing connection to the blood outlet port of the reservoir is a customer-made connection, it is likely that the connection was not made properly, or there was an issue with the tubing that had been connected to the port; however, this was not able to be confirmed.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
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6735045
• MDR Text Key: 80751267
• Report Number: 1124841-2017-00151
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: VE17
• Other Device ID Number: (01)00699753450837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2017
• 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