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

Model Number 3CX*FX25RWC

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the white portion of sampling line leading form oxygenator that is connected to the manifold cracked and started to spray blood out 20 minutes into bypass.As per the subsidiary, the user facility clamped the pre crack to mitigate the issue, and there was a few mls of blood loss.No known consequences or impact to patient.Product was not changed out.Procedure completed successfully.

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.For this reason, terumo references evaluation conclusion code 11.H6: component code: 4733 - connector/coupler.Health effect - impact code: 2199 - no health consequences or impact.Heatlh effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code #1: 1069 - break.Medical device problem code #2: 1354 - leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

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 april 18, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d1 (brand name - corrected) d3 (manufacturer - corrected email address) d4 (additional device information - added exp date; model number and unique identifier (udi) number - corrected) g1 (contact office - corrected first/given name, last name, email address, telephone number) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to correction, additional information and device evaluation) h4 (device manufacture date) h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #2: 3331 - analysis of production records investigation findings: 3259 - improper physical structure investigation conclusions: 4307 - cause traced to component failure the sample was inspected upon receipt and confirmed to have a crack in the female l-shaped connector.A representative retention sample from the same lot number was reviewed with no damage to the unit noted, specifically with the female l-shaped connector.During the investigations of similar events, replication testing found that this crack appears on the part when the l connector is over tightened on a port.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

The white portion of sampling line leading form oxygenator that is connected to the manifold cracked and started to spray blood out.

• 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 (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16765385
• MDR Text Key: 313540284
• Report Number: 1124841-2023-00092
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 2G06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2022
• 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