MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for SARNS ULTRASONIC AIR SENSOR 195274 manufactured by Terumo Cardiovascular Systems Corp..
[61712730]
(b)(4). Evaluation is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
[61712731]
It was reported that the cables which came with the level sensor and bubble detector have never worked. No other details regarding the nature of this event were provided. Diligence attempts are still ongoing.
Patient Sequence No: 1, Text Type: D, B5
[62813026]
Lab evaluation could not duplicate the reported complaint. The unit met specifications.
Patient Sequence No: 1, Text Type: N, H10
[65735001]
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
[65735002]
The event occurred during the use of the device for a non-clinical activity. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[69227992]
Patient Sequence No: 1, Text Type: N, H10
[73465284]
(b)(4). No patient involvement. The reported complaint was not confirmed. 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
| Report Number | 1828100-2016-00776 |
| MDR Report Key | 6145244 |
| Date Received | 2016-12-05 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2016-12-05 |
| 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 EILEEN DORSEY |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346636074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARNS ULTRASONIC AIR SENSOR |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-BUBBLE DETECTOR |
| Product Code | KRL |
| Date Received | 2016-12-05 |
| Returned To Mfg | 2016-11-18 |
| Model Number | 195274 |
| Catalog Number | 195274 |
| 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 CORP. |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-05 |