MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

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 prime, the manifold was blocked.Per user facility, it was not possible to get the fluid through.It can be seen in the picture that the tap for the blue valve was not seated correctly.The holes in the tap section should sit lower to line up with the tubing.No patient involvement; the product was changed out; the surgery was completed successfully.

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: 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 third 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 expiration 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, 3259, 25).Method code #1: 10 testing of actual/suspected device.Method code #2: 11 testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 analysis of production records.Results code: 3259 improper physical structure.Conclusions code: 25 cause traced to manufacturing.The affected sample was inspected and confirmed that the blue stopcock was raised, which would prohibit flow through the manifold.A representative retention sample was reviewed to find no damage to the unit, including the sampling manifold.Upon evaluation of the sample, the sampling manifold was found to have a loose blue stopcock.All sampling manifolds are leak tested during manufacturing and visually inspected; therefore, it is likely the unit was damaged during further packaging at our subsidiary or that the unit was exposed to a shock force after manufacturing that caused the stopcock snap-fit to disengage.It was not able to be determined how or when the damage occurred.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on november 3, 2020.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added described event or problem).G4 (corrected date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).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.

Event Description

Additional information was received from the subsidiary indicating that the informed date was november 2, 2020 instead of september 28, 2020.

• Brand Name: STERILE FX15RWC 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: 10781815
• MDR Text Key: 214813909
• Report Number: 1124841-2020-00254
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

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: 07/31/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XK12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/02/2020; 12/04/2020; 12/22/2020
• Supplement Dates FDA Received: 11/04/2020; 12/21/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1