MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*NX19RE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was not enough oxygenation after 1 hour and 21 minutes on bypass.As per the user facility, an initial dose of 10.000 iu of heparin was documented for the priming only.Then an initial act of 999 sec was documented after 15 minutes on bypass.The report documents usage of hemofiltration, close to the entire documented perfusion time, with a high total amount of hemofiltration of (12.000 ml).Furthermore the provided case report documents lower level of hgb and hct during the case.There was a 1 minute delay for they changed out the hlm (heart lung machine) with the new oxygenator.There was a blood loss of 100 ml.Procedure completed successfully.
Additional 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 1, 2020.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).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 213, 67, 4315).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 #1: 67 - no problem detected.Conclusions code #2: 4315 - cause not established.The affected sample was not returned.However, a representative sample from the same lot number was tested for gas transfer performance per standard test method, built into a circuit with bovine blood conditioned to 37*c and hb of 12.7g/dl.The sample was determined to meet factory specifications.Root cause cannot be determined as the sample was not returned and the issue was not able to be recreated in the laboratory.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: STERILE NX19RE W/ 4L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9911326
• Report Number: 1124841-2020-00078
• Device Sequence Number: 3435835
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XL16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STÖCKERT S5 - HLM 5SORIN 3T LH 1; STÖCKERT S5 - HLM 5SORIN 3T LH 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 70