MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-18 for STERILE NX19RE W/ 4L RES 3CX*NX19RE N/A manufactured by Terumo Cardiovascular Systems Corporation.
[188528845]
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).
Patient Sequence No: 1, Text Type: N, H10
[188528846]
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was foaming. Per user facility, the case was a aortic aneurysm dissection and they were on bypass for 3. 5 hours then another 1 to 1. 5 hours off again and then on for 15-20 minutes. The oxygenator was foaming and the end of the case, p02 dropped, they transferred to extracorporeal membrane oxygenation (ecmo), which was necessary due to the patient's right heart failure. The patient expired at a later date. There was slight blood colored plasma at the end. The product was not changed out but they did add a fx15 oxygenator into the circuit to have as a backup, (it was not used). The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2020-00035 |
| MDR Report Key | 9721858 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CATHLEEN HARGREAVES |
| Manufacturer Street | 125 BLUE BALL ROAD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE NX19RE W/ 4L RES |
| Generic Name | BLOOD GAS OXYGENATOR |
| Product Code | DTZ |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 3CX*NX19RE |
| Catalog Number | N/A |
| Lot Number | XL28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-18 |