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

Model Number 3CX*RX15RW30

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Information (3190)

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).

Event Description

The user facility reported to terumo cardiovascular that white bits on surface of the blood were observed.It is unknown when the event occurred, if there was a delay in the procedure, if the product was changed out, the results of the procedure or if there was any blood loss.

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 11, 2019.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information) h6 (identification of evaluation codes (4119, 4114, 3221, 4315).Method code #1: 4119 - insufficient information available method code #2: 4114 - device not returned results code: 3221 - no findings available conclusions code: 4315 - cause not established.The affected sample was not returned for evaluation.However, pictures provided with the complaint confirmed the existence of white biological material.A root cause could not be determined as the lot number is unknown and the sample was not returned.There are potential patient conditions with different blood levels and combinations of triglycerides, high lipid concentrations and activated white cell levels due to inflammatory response that may have occurred and contributed to the event.It could also be the residual of a platelet/white cell, (white clot) event.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: 9306911
• MDR Text Key: 168837563
• Report Number: 1124841-2019-00308
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1