MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-21 for SARNS 8000 PERFUSION SYSTEM 195274 manufactured by Terumo Cardiovascular Systems Corporation.
[93088402]
(b)(4). With the level sensor connected, they observed a red alarm light blinking. Per the manufacturer's technical support, the user facility bent the pin when trying to attach the device to the safety monitor. They will not send the suspect device back.
Patient Sequence No: 1, Text Type: N, H10
[93088403]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the device had a bent pin. As a result, an alternate device was employed. 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 | 1828100-2017-00532 |
| MDR Report Key | 7048054 |
| Date Received | 2017-11-21 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2010-03-15 |
| Date Added to Maude | 2017-11-21 |
| 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 | 2017-11-21 |
| Model Number | 195274 |
| Catalog Number | 195274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-21 |