MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for SARNS 8000 PERFUSION SYSTEM 195215 manufactured by Terumo Cardiovascular Systems Corp..
[74669130]
(b)(4). Evaluation is in progress, but not yet concluded. As per fsr, the sensor cable disconnect light emitting diode (led) illuminated. The level sensor was attached on the safety monitor. The fsr removed the level sensor and installed a back up level sensor. The unit operated to the manufacturer? S specifications.
Patient Sequence No: 1, Text Type: N, H10
[74669131]
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the alert level sensor tested bad. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[96508363]
The reported complaint was confirmed. During laboratory analysis the product surveillance technician (pst) observed ''level disconnected'' message. Most likely the cause is an internal wiring open circuit, caused by a physical damage. External cable damage was evident within one foot of the sensor-end of the cable. 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
| Report Number | 1828100-2017-00222 |
| MDR Report Key | 6548767 |
| Date Received | 2017-05-05 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-05-05 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | DTW |
| Date Received | 2017-05-05 |
| Returned To Mfg | 2017-04-24 |
| Model Number | 195215 |
| Catalog Number | 195215 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-05-05 |