MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for SARNS 8000 PERFUSION SYSTEM 195215 manufactured by Terumo Cardiovascular Systems Corporation.
[81121255]
(b)(4). As per perfusionist, they were using the prescribed level sensor gel. The customer wiped down the level sensor after each use. The field service representative (fsr) checked alert level sensor and was able to detect bubbling occurring on the polyurethane cover of the sensor. The alert level sensor was replaced. The unit operated to the manufacturer? S specifications. The product surveillance technician (pst) confirmed the reported issue. He observed? Level: not attached? Message and the most likely cause is physical damage (sensor face degradation). He found that the sensor did not properly attach when the gel was used per instructions for use (ifu). 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
[81121256]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the polyurethane cover on the level sensor was damaged. The sensor was used for the case as it still functioned. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. The product surveillance technician (pst) later observed the damage to the level sensor face caused a 'not attached' alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2017-00328 |
| MDR Report Key | 6742308 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-07-25 |
| 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 | 2017-07-25 |
| Returned To Mfg | 2017-05-01 |
| Model Number | 195215 |
| Catalog Number | 195215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-25 |