MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for SARNS 8000 PERFUSION SYSTEM 195240 manufactured by Terumo Cardiovascular Systems Corporation.
[100278493]
(b)(4). Evaluation is in progress, but not yet concluded per the manufacturer's clinical specialist the user facility mounts their pads on a curved portion of the reservoir. There were six level sensor pads that appeared to be dried out.
Patient Sequence No: 1, Text Type: N, H10
[100278494]
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads appeared dried out. 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 level sensor pads, that the customer uses with their reservoir enable the user to safely monitor the blood level in a bypass circuit reservoir. This is a device that is needed for her to conduct safe perfusion. During set up for a procedure on (b)(6) 2018, it was noticed a few pads were very dried out and deemed not usable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2018-00072 |
| MDR Report Key | 7269934 |
| Date Received | 2018-02-14 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2017-10-16 |
| Date Added to Maude | 2018-02-14 |
| 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 SYSTEM |
| Product Code | DTW |
| Date Received | 2018-02-14 |
| Returned To Mfg | 2018-01-24 |
| Model Number | 195240 |
| Catalog Number | 195240 |
| Device Expiration Date | 2018-10-27 |
| 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 | 2018-02-14 |