MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RW40C
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional 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.For this reason, terumo references evaluation conclusion code 11.                                                h6: component code: 4739 - gas exchanger.Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical, signs, symptoms or conditions.Medical device problem code: 1491 - increase in pressure.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a high pre-membrane pressure.As per the user facility, the issue was noted while on cpb, and it was continued with the administration of vasoactives without consequence to the patient.Pressures continued to gradually climb.They turned alarm limits up, to allow cpb to continue to flow.They discussed with the attending anesthetist, the surgeon was aware of issue, and the clinical lead of perfusion was consulted.Nitroprusside bolus was given to the patient, followed by a bolus directly into the oxygenator.After bolus, pre-membrane pressure came down, and it was able to flow appropriately for the patient.Nitroprusside drip was given for the remainder of cpb to prevent platelet aggregation on oxygenator until off cpb.Impact of incident: map decreased to 30's for about 5 minutes after nitroprusside bolus given, head sat's remained normal throughout.Oxygenation and co2 removal remained unaffected.No known impact or consequence to patient.The product was not changed out.The surgery was completed successfully.
Event or Problem Description
High pre-membrane pressure.
Additional 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 september 1, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h4 (device manufacture date) h6 (identification of evaluation codes 3331, 4114, 3221, 4315) type of investigation #1: 3331 - analysis of production records type of investigation #2: 4114 - device not returned investigation findings: 3221 - no findings available investigation conclusions: 4315 - cause not established the affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed.The manufacturing record and the incoming inspection records of the actual product was found to have no anomaly in the six estimated lots.No other similar report of the product with the involved product code / lot number was found.Without the actual sample, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball rd; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17673769
• Report Number: 1124841-2023-00217
• Device Sequence Number: 14966792
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2025
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: 2P19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown