MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for QUICKDRAW VENOUS CANNULA W /KIT QD22 manufactured by Edwards Lifesciences Llc.
[177026044]
Pt requiring vasoactive support went from unit to cath lab for iabp placement and back to cath lab for ecmo, until nurse identified air in ecmo circuit. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092539 |
| MDR Report Key | 9636575 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKDRAW VENOUS CANNULA W /KIT |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-01-27 |
| Model Number | QD22 |
| Catalog Number | QD22 |
| Lot Number | 62292277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |