MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RW W/4L RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 3CX*NX19RW

Device Problem Unable to Obtain Readings (1516)

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

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 arterial temperature was not reading, as a result the user facility used the oxygenator and monitored the venous and patient bladder temperature.No patient involvement.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 april 25, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).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 (11, 3331, 4114, 3259, 4307).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: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.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.

Manufacturer Narrative

This follow-up report is submitted due to terumo cardiovascular systems issuing a field removal, (b)(4).The following information is new and/or changed: b5 (additional event description).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H7 (remedial action - recall).H9 (removal number).The investigation results and conclusions, previously reported, remain the same.

Event Description

On (b)(6) 2019, terumo cardiovascular systems issued a field removal, (b)(4).

• Brand Name: STERILE NX19RW W/4L RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8549412
• MDR Text Key: 143067040
• Report Number: 1124841-2019-00106
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (y/n): N
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

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: 12/31/2019
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: XA11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 06/04/2019
• Supplement Dates FDA Received: 05/31/2019; 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1124841-06/04/2019-001-R
• Patient Sequence Number: 1