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

Model Number 3CX*RX15RW30

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

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).Results: results pending completion of investigation.Conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary, at the time of entry in partial extra-corporary circulation, the patient saturation began to go down, reaching 70%.It is unknown if there is blood loss.As per subsidiary, it was noticed that the post oxygener blood side¿s coloring was equal to the insatured venous return.Immediately, an arterial gasometry was made where the oxygen partial pressure (po2) was 35.2 mmhg, and the saturation of oxygen was 62.1%.It was processed to connect an oxygen tank to the oxygenator, thinking that it could be the blender of the heart-lung machine, and the result was the same so the anesthesiologist was requested to increase the fraction of inspired oxygen (fio2) of the ventilator to remove the pump patient, and can replace the oxygenator to an rx25, and this works.No known impact or consequence to patient.Product was changed out.Procedure 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 september 25, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g4 (date received by manufacturer) g7 (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) method code #1: 3331 - analysis of production records.Method code #2: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.Since the actual sample was not returned and no anomaly was found in the incoming inspection record, the cause of the occurrence could not be clarified.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: 10588401
• MDR Text Key: 209002135
• Report Number: 1124841-2020-00227
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: TP14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1