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

Model Number 3CX*FX15RE40C

Device Problem Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 09/16/2019

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 (cpb), short after starting the heart lung machine (hlm), pressure increase of the oxygenator.Per user facility, a few minutes after cpb for aorto-coronary bypass surgery, the pre oxygenator pressure started rising gradually whereas the post oxygenator pressure was constant.After 7 min of cpb, the pre oxygenator pressure rose to 500 mm hg abruptly with the delta p of 250 mm hg, and the pump was completely stopped due to high pressure.The act during that particular moment was 508 sec.After they informed the surgeons, two of the perfusionists changed the whole machine within 7 minutes.During this maneuver, the aorta was not clamped, hence he was ventilated and he was hemodynamically stable.*no consequences or impact to patient *product was changed out *there was 300 ml blood loss *procedure 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: (b)(4).The affected sample was visually inspected upon receipt and did not find any obvious anomalies, such as break.The sample was then rinsed, dried and built into a circuit.Bovine blood was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the factory's specifications and no obstruction was confirmed.The bovine blood was circulated in the circuit for another 6 hours and physiological saline solution was flow into the blood channel and no clot formation that could lead to an increase in the pressure was confirmed.The investigation result verified that the actual sample after having been rinsed was the normal product presenting no issue relating to the increase in the pressure.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 october 6, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).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).H4 (device manufacture date).A third follow-up will be submitted upon completion of the investigation and/or sumission 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: 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: 9160288
• MDR Text Key: 162528145
• Report Number: 1124841-2019-00274
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: XD11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/06/2019
• Supplement Dates Manufacturer Received: 10/18/2019; 11/20/2019; 12/16/2019
• Supplement Dates FDA Received: 11/07/2019; 12/05/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 68