MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-23 for SARNS 8000 PERFUSION SYSTEM 195274 manufactured by Terumo Cardiovascular Systems Corporation.
[114809988]
Evaluation is in progress, but not yet concluded. The user turned the level sensors off and completed the case without incident.
Patient Sequence No: 1, Text Type: N, H10
[114809989]
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the low level alarm was sounding intermittently while there was no low level condition present. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2018-00382 |
| MDR Report Key | 7712445 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-23 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2008-11-18 |
| Date Added to Maude | 2018-07-23 |
| 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 | 2018-07-23 |
| Returned To Mfg | 2018-07-09 |
| 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 CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |