MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for SARNS 8000 PERFUSION SYSTEM 195274 manufactured by Terumo Cardiovascular Systems Corporation.
[90252183]
(b)(4). The field service representative (fsr) observed a small tear in the alarm sensors cable, part of the alarm level sensor, close to the sensor head. The alarm level sensor was replaced. The unit operated to the manufacturer? S specifications. The defective part was returned to the manufacturer. 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
[90252184]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor was not working. 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 | 1828100-2017-00462 |
| MDR Report Key | 6938978 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-11-01 |
| Date Added to Maude | 2017-10-10 |
| 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 | 2017-10-10 |
| Returned To Mfg | 2017-10-03 |
| 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 | 2017-10-10 |