MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Dent in Material (2526)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during non clinical activity, they found notches on the reservoir.No patient involvement.

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).

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 (b)(6), 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) 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, 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 #3: 3331 - analysis of production records investigation findings: 3259 - improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was returned and confirmed to have a marking on the outside of the reservoir housing.Reservoir retention housing lot numbers 020521a, 020821a, and 021321a were inspected with none of the housings displaying any markings/scratches in and around the affected area.On the production floor, 13 units were visually inspected prior to leak test.The 13 units were noted to have no markings/scratches in the affected area.The 13 units were then leak tested and put on the final assembly table by the operator which involves placing the units on a mounting post.The units went around the table to final inspection where they were visually inspected for any damage.Of the 13 units, 4 were noted to have slight scratches.A rejected unit was used to re-create the reported event.The unit was placed on the table using normal force and purposefully contacted the mounting post.A marking was noted on the housing that is similar to the reported event.Using k4855w (final inspection and packaging in-process inspection criteria) that states, no scratches (outside blood contact area) = 10mm, the mark was measured and found to be within specification.A representative retention sample was inspected and noted to have not have any markings or abnormalities on the reservoir housing.Upon evaluation of the returned sample and re-creating the reported event, the complaint is confirmed.The damage seen on the returned sample, likely occurs during the manufacturing process when the operator puts the unit on the final assembly table and inadvertently contacts the mounting post.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25REC 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: 14455715
• MDR Text Key: 300320290
• Report Number: 1124841-2022-00113
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: ZN08R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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