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 |