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

Model Number 3CX*FX15RW40C

Device Problem Decrease in Pressure (1490)

Patient Problem Blood Loss (2597)

Event Date 08/19/2020

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, they noticed dropping of oxygenation.As per user facility the patient came in at (b)(6) hospital (b)(6) on (b)(6) 2020 with symptoms constant coughing, nausea , pain upper left stomach area.His condition became worse , transfer to university hospital leuven.According perfusionist he developed multiple organ failure like kidney issues, liver failure and cardiogenic shock.The procedure was placement of left ventricular assist device (lvad) heart ware on a patient during bypass, however prior to the lvad first impella was placed for left ventricle support but system needed to change out to another impella, but failed again.The left ventricle support was not enough.The case was started around 2:57pm, cdi 500 was used and oxygenation from the start was perfect.First blood gas sample at 15.15pm with an fio2 of 60% and 2l flow po2= 251 pco2= 36.The second blood gas sample at 15.24pm with an fio2 of 100% plus 10lgasflow po2 dropped to 84 and pco2 went up to 43, even went to po2= 73.The cdi500 gave the same information and they decided to changed out the oxygenator.At around 15.40 pm they changed out the oxygenator at first 100%fio2 at 2.5 l/flow, po2= 503 pc02 31.At first the values were fine.After 20 minutes the same event as above occurred.Cdi 500 gave decreasing po2 levels and increasing pco2 levels.No data was stored and no extra blood gas samples were taken.On pump time was 71 minutes and they decided to wean the patient immediately using cdi.Blood loss estimated 1 liter (cellsaver).Product was changed out.Procedure 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: 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 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.Visual inspection of the sample found no obvious anomaly that could lead to poor gas transfer performance.After having been rinsed and dried, it was tested for its gas transfer performance and found no anomalies and meet the factory specification.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information was received indicating that on (b)(6) 2020 the patient was admitted with dilated cardiomyopathy.On (b)(6) an impella implantation was done; however on (b)(6) the impella was replaced due to hemolysis and on (b)(6) they switch from impella to lvad still because of hemolysis.

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: b5: (describe event or problem, added new information).B7: (other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.Added new information).G4: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to additional information).H6 11 - conclusion not yet available.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 september 8, 2020.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: 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: 10504582
• MDR Text Key: 206170750
• Report Number: 1124841-2020-00211
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• 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: 09/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPELLA
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 60