MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 4000 ML; BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RE40

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

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 presented a retention of co2 according to the laboratory report.It is unknown if there was a delay in the procedure.No consequence or impact to patient.Product was not changed out.Procedure was completed successfully.

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 11, 2018.(b)(4).The returned sample was visually inspected no obvious anomaly, such as break were found.After having been rinsed and dried, the unit was tested for its oxygen (o2) transfer volume and carbon dioxide (co2) removal volume in accordance with the factory's shipping inspection protocol and verified that the actual sample was the normal product with no issue in the gas transfer performance.With the absence of the involved pump record to be evaluated or the detailed information about the events leading up to this complaint, it is difficult to determine the definitive cause of this complaint.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HOLLOW FIBER OXY WITH 4000 ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7956271
• MDR Text Key: 123393023
• Report Number: 1124841-2018-00255
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450158
• UDI-Public: (01)00699753450158
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 3CX*RX15RE40
• Device Catalogue Number: N/A
• Device Lot Number: VM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1