MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-12 for ADVANCED PERFUSION SYSTEM 1 816570 manufactured by Terumo Cardiovascular Systems Corporation.
[183385159]
The field service representative (fsr) confirmed that the roller pump did not respond to the low level alarm due to the fact that the level sensor was not plugged into the alarm port on the level pod. There was an alert sensor plugged into the alert port on the level pod. The perfusionist wanted the alert sensor plugged into the alarm port in the level pod. The pump responded correctly to the low level alarm. The unit operated to the manufacturer's specifications.
Patient Sequence No: 1, Text Type: N, H10
[183385160]
It was reported that the roller pump was not responding to alarms. No other details regarding the nature of this event were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2020-00120 |
| MDR Report Key | 9825580 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOUGLAS PATTON |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED PERFUSION SYSTEM 1 |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1 |
| Product Code | DTQ |
| Date Received | 2020-03-12 |
| Model Number | 816570 |
| Catalog Number | 816570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-12 |