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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number QD22
Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  Injury  
Manufacturer Narrative
The subject device is not available for evaluation, as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.The device history record (dhr) was not reviewed as the lot number was not provided.Also, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Based on the information received, use error most likely contributed to the event.There was no indication or allegation of a device malfunction contributing to the event.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.
 
Event Description
Edwards received information that failure of blood removal occurred temporarily during use of the 22 fr venous cannula which was connected to cardiopulmonary bypass machine.This occurred because the customer pulled or moved the cannula too much from the smaller patient body and the fifth side hole exposed in the air which led the cannula to suck air.There was no exchange of cannula.There was no delay in the procedure.There were no patient complications reported.The customer is a frequent user of the 25 fr cannula not of the 22 fr device.
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
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Brand Name
QUICKDRAW VENOUS CANNULA
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key7682419
MDR Text Key113800557
Report Number3008500478-2018-00074
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
K981995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberQD22
Device Catalogue NumberQD22
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/19/2018
Initial Date FDA Received07/12/2018
Supplement Dates Manufacturer Received07/23/2020
Supplement Dates FDA Received09/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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