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 |