MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for N/S ARTERIAL FILTER XC (TOTED) 3ZZAF200XA N/A manufactured by Terumo Cardiovascular Systems Corporation.
[99133258]
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. For this reason, terumo references evaluation conclusion code 11. (b)(4). Results pending completion of evaluation. Conclusions: conclusion not yet available-evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[99133259]
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there is a particulate in the fiber bundle. No patient involvement. Product was changed out. Procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2018-00016 |
| MDR Report Key | 7238607 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-03-23 |
| Date of Event | 2017-12-25 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2017-05-30 |
| Date Added to Maude | 2018-02-02 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | N/S ARTERIAL FILTER XC (TOTED) |
| Generic Name | ARTERIAL BLOOD FILTER |
| Product Code | DTM |
| Date Received | 2018-02-02 |
| Model Number | 3ZZAF200XA |
| Catalog Number | N/A |
| Lot Number | VF29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-02-02 |