MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-04 for HERCULES III 001-401-161 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[132227218]
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).
Patient Sequence No: 1, Text Type: N, H10
[132227219]
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arm did not work during the procedure. There was unknown delay and blood loss. It was also unknown if the product was changed out or if the surgery was completed successfully. Due to the unknown information for this event, it is being reported. Terumo continues to attempt to gain more information regarding this event from the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2019-00006 |
| MDR Report Key | 8219906 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-04 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | DTZ |
| Date Received | 2019-01-04 |
| Model Number | 001-401-161 |
| Catalog Number | N/A |
| Lot Number | 71134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Brand Name | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | MSW |
| Date Received | 2019-01-04 |
| Returned To Mfg | 2019-01-18 |
| Model Number | 001-401-161 |
| Catalog Number | N/A |
| Lot Number | 71134 |
| 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 | 2019-01-04 |