MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-10 for SARNS 8000 MODULE PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corp..
[69900444]
(b)(4). The field service representative (fsr) was not able to duplicate the reported issue. He triggered the uas multiple times and was able to reset it each time. The fsr performed preventive maintenance/inspection and the uas operated to manufacturer's specifications. The system was ready for clinical use. 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
[69900445]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the ultrasonic air sensor (uas) was not resetting. 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 | 1828100-2017-00120 |
| MDR Report Key | 6396485 |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-02-14 |
| Device Manufacturer Date | 2007-10-15 |
| Date Added to Maude | 2017-03-10 |
| 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 MODULE PERFUSION SYSTEM |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM |
| Product Code | KRL |
| Date Received | 2017-03-10 |
| Model Number | 5773 |
| Catalog Number | 5773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-03-10 |