MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for SARNS 8000 PERFUSION SYSTEM 195240 manufactured by Terumo Cardiovascular Systems Corporation.
[90312366]
No consequences or impact to patient. Failure to adhere or bond. Adhesive. Per the customer, the sensors were mounted on an area that was curved.
Patient Sequence No: 1, Text Type: N, H10
[90312367]
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pad popped off of the reservoir and the stop pump safety intervention was initiated. 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. Per clinical review: the customer has had numerous complaints on their level sensor pads coming off the reservoir, with this being the most recent. They currently use the medtronic rounded reservoir for their procedures. During the bypass procedure the level sensor pads came off their reservoir and activated the safety intervention on their 8000 arterial roller pump to stop the pump. They were able to disable the level sensor and restart the pump. The incident did not delay the surgical procedure, and there was no harm to the patient or blood loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2017-00466 |
| MDR Report Key | 6945490 |
| Date Received | 2017-10-12 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2017-10-12 |
| 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. EILEEN DORSEY |
| 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 | 2017-10-12 |
| Returned To Mfg | 2017-11-15 |
| Model Number | 195240 |
| Catalog Number | 195240 |
| 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 | 1. Required No Informationntervention | 2017-10-12 |