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

Model Number 3CX*FX25REC

Device Problem Filtration Problem (2941)

Patient Problem Blood Loss (2597)

Event Date 05/20/2019

Event Type  Injury  

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 during cardiopulmonary bypass, a clot formation in the cardiotomy portion of the reservoir was observed.Per user facility, this was noticed by a non-gradient blood level in the filter part.An exchange of the heart lung machine, including the disposables on the hypothermic patient, had to take place.In pea (pulmonary endarterectomy) in deep hypothermia (18-20°c).Cold agglutinin is measured in the laboratory.(cross-blood determination) 15 blood transfusions in addition to fresh frozen plasma and platelet concentrate was used.There was an unknown amount of blood loss.It is unknown if the 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 june 11, 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 application evaluated 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.The affected sample was returned for evaluation.There were some small clots observed in the reservoir, however they were readily washed out during the bovine blood testing, otherwise there were no visual defects noted upon receipt.The returned sample was tested for clotting with bovine blood (hct 35.9% and 37.1*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.The retention sample was tested for clotting with bovine blood (hct 35.9% and 37.1*c) at 4 l/minute for one hour with no clotting observed in the cardiotomy portion of the reservoir.It is likely that patient conditions or inadequate heparinization of the patient contributed to the formations of clots within the reservoir filter.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE 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: 8688507
• MDR Text Key: 147641827
• Report Number: 1124841-2019-00165
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: XC04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 57