MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-13 for BIO CONSOLE 560 560BCS1 manufactured by Perfusion Systems.
[179254859]
The bio-console instrument was analysed by a medtronic field service technician and the reported ramp up to 6,000 rpm was verified during service. The issue was resolved by replacing the assy, 560 m/p module. Preventive maintenance was performed per specifications. Trends for this product are monitored. Device evaluation was carried out in the facility by a medtronic service technician. The date service was carried out has been used as the return date. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179254860]
Medtronic received information that during use this bio-console instrument ramped up to 6,000 rpm. The external motor drive was replaced and the issue occurred again. The instrument was changed out with a backup and there was no resulting adverse patient effect. It was reported that the customer used the hand crank when switching over between motors and bio-consoles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2020-00009 |
| MDR Report Key | 9705870 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2020-02-13 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO CONSOLE 560 |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | DWA |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-15 |
| Model Number | 560BCS1 |
| Catalog Number | 560BCS1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |