MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-18 for STERILE FX25RWC W/ RES 3CX*FX25RWC N/A manufactured by Terumo Cardiovascular Systems Corporation.
| Report Number | 1124841-2020-00034 |
| MDR Report Key | 9721617 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-10-07 |
| 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 FX25RWC W/ RES |
| Generic Name | BLOOD GAS OXYGENATOR |
| Product Code | DTZ |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 3CX*FX25RWC |
| Catalog Number | N/A |
| Lot Number | XM07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-18 |