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

Model Number 3ZZ*FX25RECA

Device Problem No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 07/15/2019

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 couldn't get flow.As per the user facility, they came off bypass gave ½ of protamine, patient crashed, back on pump and couldn¿t get flow.Surgeon moved aortic cannula and got 4 liters and went back on bypass.No consequences or impact to patient.Product was not changed out.Procedure was completed successfully.

Event Description

New information was obtained indicating that the patient had a stroke after the case.Also the facility was draining the reservoir after cpb, and then re-priming with crystalloid solution.*there was a small delay in the case.

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 august 2, 2019.The actual sample was returned and visually inspected upon receipt.No anomalies found such as break in the appearance.After having been rinsed, the actual sample was built into a circuit.Bovine blood was circulated in the circuit while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet factory's specifications, and no obstruction was noted inside the actual sample.The actual sample was then flushed with water, and no clot formation was confirmed.Review of device history record and product release decision control sheet of the involved product/lot number combination confirmed there were no anomalies in them.It was verified on the investigation result that the actual sample was the normal product without presenting any issue which could have led to the reported event.With no anomaly found on the actual sample, the cause of this complaint cannot be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8855396
• MDR Text Key: 153123846
• Report Number: 1124841-2019-00214
• Device Sequence Number: 1
• Product Code: DTZ
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: XD18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other