MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40C

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 02/28/2019

Event Type  Injury  

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).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed.  there was a 5 minutes delay.There was a blood loss of 144 ml.The product was changed out.The procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information indicates that they were able to come off cardiopulmonary bypass (cpb) to change out the oxygenator with anesthesia ventilating the patient during the change out procedure.It was also stated that the patient's "head sats" (cerebral oximetry monitoring) did not drop below baseline during the event.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.  method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The actual sample was received and was visually inspected upon receipt with no obvious anomalies such as break in the appearance.After having been rinsed and dried, the actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.Bovine blood was arranged and was circulated in the oxygenator module.No anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting the factory specifications.Review of device history record and product release decision control sheet of the involved product/lot number combination confirmed there was no indication of production-related anomaly or of nonconforming inspection results.Based on the findings, the actual sample has no issue in the gas transfer performance.With no detailed information about the events leading up to the reported complaint, it is difficult to determine the definitive root cause of this complaint.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8433377
• MDR Text Key: 139225614
• Report Number: 1124841-2019-00073
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: WP17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 05/03/2019
• Supplement Dates FDA Received: 04/16/2019; 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 71