MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-30 for SARNS 8000 PERFUSION SYSTEM 16413 manufactured by Terumo Cardiovascular Systems Corporation.
[146640326]
Per fsr, the unit was not fixed because the temperature/pressure board was not available to replace. The user facility's biomedical technician removed the arterial monitor. The unit operated to the manufacturer's specifications.
Patient Sequence No: 1, Text Type: N, H10
[146640327]
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the unit was not reading temperature from the arterial port on the arterial monitor. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00282 |
| MDR Report Key | 8655319 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-06-25 |
| Device Manufacturer Date | 2007-09-18 |
| Date Added to Maude | 2019-05-30 |
| 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 | MR. DOUGLAS PATTON |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | DTW |
| Date Received | 2019-05-30 |
| Model Number | 16413 |
| Catalog Number | 16413 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |