MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML; BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RW30

Device Problem Use of Device Problem (1670)

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

Event Date 10/23/2018

Event Type  Injury  

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 during cardiopulmonary bypass, there was no color change with fio2 at 65% and sweep at 2.5 on a 50kg pt.The fio2 was increased to 100% and sweep increased to 4 to see if it would help and opened the purge on top of the oxygenator to help recirculate the blood.The po2 at 100% was only 41, anesthesia turned on the vent for the o2 to rise.The po2 only got to 45.At that point, it was decided to change out the oxygenator.Once changed out and deaired, the po2 was at 188 with just 50%.Per user facility the patient was being ventilated as they went on bypass.There was a delay for 10-15 minutes.Product was changed out.There was a blood loss of 150 ml.After change out, surgery was completed successfully.Post op, patient was sitting up in bed and doing well, following commends,.

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 november 12, 2018.  (b)(4).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.(b)(4).The actual sample was visually inspected upon receipt and did not find any anomalies such as break in the appearance.After having been rinsed and dried, the actual sample was tested for its o2 transfer volume and co2 removal volume.No anomalies were revealed in the gas transfer performance with the obtained values meeting the factory specifications.During the test, the arterial and venous blood were comparatively observed for their colors, and arterial blood was found to be brighter than the venous blood.Review of the device history record of the involved product/lot number combination confirmed no indication of product-related anomaly.Investigation result verified that the actual sample was with the normal product with no issue in the gas transfer performance.It is possible that the volume of o2 supply was not sufficient for the volume of the patient's o2 consumption.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HOLLOW FIBER OXY WITH 3000 ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8062603
• MDR Text Key: 126932006
• Report Number: 1124841-2018-00286
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450127
• UDI-Public: (01)00699753450127
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: WH16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 50