MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for SARNS 8000 PERFUSION SYSTEM 16413 manufactured by Terumo Cardiovascular Systems Corporation.
[80054242]
(b)(4). Evaluation is in progress, but not yet concluded. Per field service representative (fsr), the arterial monitor functions to specification. The fsr could not duplicate the complaint. A replacement monitor was installed. The unit is operating within manufacturer's specifications. Unit was returned to manufacturer for additional evaluation.
Patient Sequence No: 1, Text Type: N, H10
[80054243]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the display for arterial pressure was not showing any information. They used cardioplegia monitor channel b in place of arterial pressure for this case. 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 | 1828100-2017-00300 |
| MDR Report Key | 6700494 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 1994-04-14 |
| Date Added to Maude | 2017-07-11 |
| 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 | 2017-07-11 |
| Returned To Mfg | 2017-06-28 |
| Model Number | 16413 |
| Catalog Number | 16413 |
| ID Number | GTIN (01)00886799000205 |
| 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 | 2017-07-11 |