MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX25RECA

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2019

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 after cardiopulmonary bypass, the circuit was flushed with crystalloid.The volume infused through prime line and was held up, however it did not break through to main portion of reservoir.Per user facility, circuit flushed with crystalloid when they noticed that the level alarm was going off.Volume that was being unfused into the reservoir through the cardiotomy was being held up in that section and not draining into main reservoir compartment through the cardiotomy sock.No bioglue/topical hemostatic agents used during the case, and all suckers were off prior to protamine being administered.Per clinical specialist, even though the pump sucker(s) was turned off prior to protamine administration, the vents were still being utilized until 50% of the protamine was infused.Protamine was being sucked into the reservoir via the vent(s).No patient involvement as this occurred after cardiopulmonary bypass.

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: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Conclusions code: 67 - no problem detected.The affected sample was returned for evaluation.A clot was observed in the cardiotomy filter, however, it was readily washed out during decontamination, and no other anomalies noted upon receipt.It was then tested for clotting with bovine blood (hct 36.1% and 37.2*c) at 4 l/minute for one hour with no clotting observed in the cardiotomy portion of the reservoir.A representative retention sample from the same lot number was obtained, no visual anomalies noted.It was also tested the same way and no clotting observed in the cardiotomy portion of the reservoir.The issue could not be replicated.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Please disregard the reference to a past communication made by the clinical specialist that was previously submitted, indicating that the pump sucker(s) was turned off prior to protamine administration, the vents were still being utilized until 50% of the protamine was infused and the protamine was being sucked into the reservoir via the vent(s).

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 august 30, 2019.Upon further investigation of the reported event, the following information is new and/or changed: 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.

• Brand Name: NS FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8951882
• MDR Text Key: 159601135
• Report Number: 1124841-2019-00239
• Device Sequence Number: 1
• Product Code: DTZ
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: WP17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1