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 2019-08-26 for AFFINITY CP CENTRIFUGAL PUMP CBAP40 manufactured by Perfusion Systems.
| Report Number | 2184009-2019-00053 |
| MDR Report Key | 8930517 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-26 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-07-31 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2019-04-09 |
| Date Added to Maude | 2019-08-26 |
| 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 | AFFINITY CP CENTRIFUGAL PUMP |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2019-08-26 |
| Returned To Mfg | 2019-08-21 |
| Model Number | CBAP40 |
| Catalog Number | CBAP40 |
| Lot Number | 217443372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-08-26 |