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

Model Number 3CX*RX15RE40

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2019

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 prior to cardiopulmonary bypass, during setup, the oxygenator would not read the arterial temperature.No consequences 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 june 28, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 additional device information - added exp date; e1 corrected last name; g4 date received by manufacturer; g7 indication that this is a follow-up report; h2 follow-up due to correction and additional information; h4 device manufacture date; h6 identification of evaluation codes (11, 3331, 4114, 213, 67.Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331- analysis of production records.Method code #3: 4114 - device not returned.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The sample was not returned for evaluation.A retention sample from the same product/lot number was tested and found to be functioning properly.An engineering investigation and capa have been initiated to determine a definitive root cause.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: 8745724
• MDR Text Key: 149645884
• Report Number: 1124841-2019-00179
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450158
• UDI-Public: (01)00699753450158
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 3CX*RX15RE40
• Device Catalogue Number: N/A
• Device Lot Number: XA07 OR XA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1