MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-07 for SARNS 8000 PERFUSION SYSTEM 16413 manufactured by Terumo Cardiovascular Systems Corporation.
[132358578]
As per the manufacturer's technical support specialist, the unit has reached end of service life (eosl) so it is unable to be serviced. No parts will be returned as manufacturer is unable to service the unit. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[132358579]
It was reported that during preventive maintenance (pm) of the device, the unit did not turn on. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2019-00010 |
| MDR Report Key | 8222764 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2018-12-14 |
| Device Manufacturer Date | 1995-01-24 |
| Date Added to Maude | 2019-01-07 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2019-01-07 |
| Model Number | 16413 |
| Catalog Number | 16413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-07 |