QUICKDRAW VENOUS CANNULA W /KIT QD22

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5092539
MDR Report Key9636575
Date Received2020-01-27
Date of Report2020-01-23
Date of Event2020-01-20
Date Added to Maude2020-01-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUICKDRAW VENOUS CANNULA W /KIT
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-01-27
Model NumberQD22
Catalog NumberQD22
Lot Number62292277
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES LLC
Manufacturer AddressIRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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