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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 QD25
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Material Separation (1562); Gas/Air Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to edwards for evaluation.Evaluation is in progress.These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).In this case, a massive amount of air was aspirated to the extra-corporeal tube right after the initiation of the cardiopulmonary bypass.The connector of the cannula was found loose.The cannula was pushed into the connector and secured.Based on the information received the cause of the event cannot be determined.Once additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.
 
Event Description
Edwards received information that a small amount of air was aspirated to the extra-corporeal tube right after the cardiopulmonary bypass (cpb) was started during use.The duration was about ten (10) to fifteen (15) seconds.Cannula was checked then the connector was almost halfway off the 25fr cannula body.The cannula was pushed into the connector, but it was loose due to the blood adhesion.The connector was fixed by tie gun at two sites and operation was continued.The customer commented that the air was not aspirated into the patient and no blood leakage was observed from the connector.The customer also commented they checked the connection after surgery and the connector was looser to the cannula body when comparing to the same type of the products.The customer used it in the standard way and the connector was not disconnected and connected.The patient status was reported as "recovered".The cannula was used for minimally invasive cardiac surgery (mics) to perform mitral valvuloplasty.The customer requested a preventive action such as gluing the connector.The device will be returned for evaluation.
 
Event Description
Edwards received information that a small amount of air was aspirated to the extra-corporeal tube right after the cardiopulmonary bypass (cpb) was started during use.The duration of air aspiration was about ten (10) to fifteen (15) seconds after the cpb was started.Cannula was checked then the connector was almost halfway off the 25fr cannula body.The cannula was pushed into the connector, but it was loose due to the blood adhesion.The connector was fixed by tie gun at two sites and operation was continued.The problem occurred within ten (10) minutes after the cannula was inserted to the patient.The cpb was not pulling vacuum on the venous side as the cpb was just started.The cpb had drawn about 1.5 litter of blood by the gravity drainage but it was not much air to cause air block.The air was not aspirated into the patient and no blood leakage was observed from the connector.After surgery, the connection was checked and the connector was looser to the cannula body when comparing to other products of the same model.The customer commented that maybe it was related to blood adhesion on the connector.The customer used it in the standard way and the connector was not disconnected and connected.The patient status was reported as "recovered".The cannula was used for minimally invasive cardiac surgery (mics) to perform mitral valvuloplasty.The total cpb time was two-hundred seventy-one (271) minutes.The customer requested a preventive action such as gluing the connector.The device was returned for evaluation.
 
Manufacturer Narrative
H3.Device evaluation: customer complaint of disconnected connector was not confirmed with assessment.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the connector of the cannula was intact and remained attached to the rest of the cannula.Connector was not loose and would not disconnect from cannula when manipulated.No visual damage or other abnormalities were found to the returned device.Photos provided appeared consistent with lab findings.H10.Additional manufacturer narrative: updated sections b5, d4 (expiration date), h3, h4, and h6 (method).Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.
 
Event Description
Edwards received information that a small amount of air was aspirated to the extra-corporeal tube right after the cardiopulmonary bypass (cpb) was started during use.The duration of air aspiration was about ten (10) to fifteen (15) seconds after the cpb was started.Cannula was checked then the connector was almost halfway off the 25fr cannula body.The cannula was pushed into the connector, but it was loose due to the blood adhesion.The connector was fixed by tie gun at two sites and operation was continued.The problem occurred within ten (10) minutes after the cannula was inserted to the patient.The cpb was not pulling vacuum on the venous side as the cpb was just started.The cpb had drawn about 1.5 litter of blood by the gravity drainage but it was not much air to cause air block.The air was not aspirated into the patient and no blood leakage was observed from the connector.After surgery, the connection was checked and the connector was looser to the cannula body when comparing to other products of the same model.The customer commented that maybe it was related to blood adhesion on the connector.The customer used it in the standard way and the connector was not disconnected and connected.The patient status was reported as "recovered".The cannula was used for minimally invasive cardiac surgery (mics) to perform mitral valvuloplasty.The total cpb time was two-hundred seventy-one (271) minutes.The customer requested a preventive action such as gluing the connector.The device was returned for evaluation.Additional information from the customer: the customer did not wiggle or bend the connector.They did not find any difficulty connecting, so they did not add any extra force.The zip ties were connected after connection were completed.The zip ties were present until cannula removal.The cannula was not used abnormally; the user was experienced, there was no new situation, no differences in connection/tubing/equipment, there was no situation where excessive force was added.The cannula was clamped in the middle of non-reinforced clamp site.The cannula was connected to the cpb tubing while holding the connector proximal to the barbed location.The cannula joint was on the patient body without strong tension added to the connector.It was not hanging.
 
Manufacturer Narrative
H10: additional manufacturer narrative: updated section b5.
 
Manufacturer Narrative
H10.Additional manufacturer narrative: updated section h6.Root cause cannot be determined at this time.
 
Manufacturer Narrative
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
1 edwards way
irvine CA 92614
MDR Report Key10323747
MDR Text Key208015928
Report Number3008500478-2020-00202
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,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/10/2021
Device Model NumberQD25
Device Catalogue NumberQD25
Device Lot Number62563390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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