MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-31 for SARNS 8000 PERFUSION SYSTEM 195240 manufactured by Terumo Cardiovascular Systems Corporation.
[81569361]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[81569362]
It was reported that the level sensor pad was falling off and would not stick enough. No other details regarding the nature of this event were provided. Diligence is ongoing to obtain additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2017-00333 |
| MDR Report Key | 6754381 |
| Date Received | 2017-07-31 |
| Date of Report | 2017-10-06 |
| Date Mfgr Received | 2017-10-04 |
| Device Manufacturer Date | 2017-07-28 |
| Date Added to Maude | 2017-07-31 |
| 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. KATIE HOYT |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | DTW |
| Date Received | 2017-07-31 |
| Model Number | 195240 |
| Catalog Number | 195240 |
| Lot Number | 835339 |
| Device Expiration Date | 2018-10-27 |
| 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 | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-31 |