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

Model Number 3CX*FX15RW40C

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation, however, 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). Results: results pending completion of investigation; conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a decreased performance of oxygenator during run. Per clinical specialist the patient was in for placement of left ventricle assist device (heartmate 3). The lactate levels were high (>4), the ph was acidotic with base deficits of >-7. 5, low hco3 levels. The first act level was 999, which is not considered a measurable level so it's unknown as to what the true anticoagulation level was at that point in time, also it was mentioned that patient had high bilirubin level. The po2 values were good, the pco2 values were slightly elevated, arterial saturations, the venous saturation values, hemoglobin and hematocrit were all good. The do2 values were adequate. The patient has no urine output per the record attached, there was 3900 ml of volume removed via hemofiltration. No known impact or consequences to patient; the product was not changed out; the surgery was completed successfully.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 10632080
• MDR Text Key: 219177872
• Report Number: 1124841-2020-00233
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 09/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial