MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

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 when the perfusionist touched the luers located on the curved venous inlet and it caused an allergic reaction to her hand/arm.Another person also touched the luers and also had a reaction.No patient involvement.Product was 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 apr 10, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability ¿ added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer ¿ a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) 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 to fda in accord with applicable regulations.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 and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - actual device evaluated.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned cap was visually inspected and no anomalies were noted.Additionally, a representative retention sample from the same lot number combination was obtained.There were no visual anomalies noted with the retention caps.Ftir analysis was conducted on the received sample, the retention sample, and an additional sample from production.The ftir analysis was completed by an independent laboratory.Each of the samples came back with no presence of foreign contamination.The analysis indicated polypropylene, which is the composition of the cap.The investigation verified that the sample did not contain any foreign contaminates.A root cause for the allergic reaction could not be determined as there were no foreign contaminates present.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8501031
• MDR Text Key: 141754162
• Report Number: 1124841-2019-00093
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: WP17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1