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

Model Number 3CX*FX25RWC

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  malfunction  

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed a leakage on the temperature connection.It is unknown whether there was delay in the procedure, whether the product was changed out and whether the surgery was completed successfully, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.Per facility, the unit was mounted and primed on the pump for 24 hours.The leak occurred at the temp probe connection on the oxygenator.This was the emergency pump.They tried to solve it but were unsuccessful.

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 january 12, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5: (describe event or problem).D4: (additional device information - added expiration date).D5: (suspected medical device - operator of device).E1: (initial reporter - added reporter name, email address & telephone number).E2: (initial reporter - health professional).E3: (initial reporter - occupation).G3 (date received by manufacturer).G6: (indication that this is a follow-up report).H2: (follow-up due to additional information and device evaluation).H3: (device evaluated by manufacturer).H4: (device manufacture date).H6: (identification of evaluation codes 10, 11, 3331, 3259, 25).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 #3: 3331 - analysis of production records.Investigation finding: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected and to noted that the arterial thermistor was not affixed to the oxygenator.However, there was bonding agent noted within the port.A representative retention sample was obtained, and pressure tested to 1100mmhg for 10 minutes, no leaks were noted.A training was conducted with the production associates to make them aware of this event and to ensure that all thermistors, and other components, are properly assembled and inspected on the reservoir and oxygenator.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received indicated that there was no blood loss and the product was changed 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16150347
• MDR Text Key: 307220561
• Report Number: 1124841-2023-00013
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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: 2A24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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