MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE30C

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/03/2019

Event Type  malfunction  

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 the oxygenator leaked and the surgeons can not perform the procedure with it.It is unknown when this event occurred, whether the product was changed out, 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.

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 october 24, 2019.(b)(4).The affected sample was not returned for evaluation; therefore, therefore a thorough investigation could not be conducted.A representative retention sample was reviewed for damage on the unit with no anomalies noted.Root cause cannot be determined with the information provided and the sample was not returned.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received that the event occurred during prime.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.  upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluated anticipated by manufacturer).The sample was received on 12/2/19, after the final medwatch was submitted on 11/22/19.An additional follow-up will be submitted upon completion of the investigation, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer) ; g7 (indication that this is a follow-up report) ; h2 (follow-up due to additional information and device evaluation) ; h3 (device evaluated by manufacturer) ; h6 (identification of evaluation codes 10, 3259, 4307).Method code #1: 10 - testing of actual/suspected device.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The visual inspection of the actual sample with naked eye did not find any anomaly, such as break that could lead to the leak.However, it was found that the oxygenator had come off the support arm and the luer thermistor bonded to a port of the oxygenator had been distorted.A colored saline solution was flowed into the blood channel of the oxygenator module by gravity, and leaked out of both lateral sides.After the lateral side of the oxygenator housing was disassembled, while the colored saline solution was being flowed into the oxygenator module, the fiber winding was observed under magnification for the location of the leak, and revealed that the leak was occurring in the inside of the fiber located on the most perimeter of the fiber winding.The x-ray ct evaluation of the leaking segment revealed that the urethane filling and fiber embedded have been cracked.A review of the device history record and the incoming inspection record of the involve product code/lot number combination confirmed there were no indications of anomaly in them.Investigation results, as a cause of occurrence, it is assumable that leak occurred through the cracks generated in the urethane filling and the fiber embedded inside.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9232643
• MDR Text Key: 164342573
• Report Number: 1124841-2019-00288
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: WN26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1