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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA CANNULA, CATHETER

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EDWARDS LIFESCIENCES 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA CANNULA, CATHETER Back to Search Results
Model Number OPTI22
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/07/2019
Event Type  Injury  
Manufacturer Narrative
Udi #: (b)(4). The purpose of the vent cap is to allow air to temporally vent while preventing blood loss. The vent cap is then removed and discarded when the cannula is connected to the circuit. On occasion, there may be incidences where a small amount of blood escapes through the vent. This presents minimal risk to the patient and does not indicate a malfunction of the device. Per image evaluation, the customer provided images showed two labels on the original sterile barrier pouch packaging from reported model and lot/serial number. Report of blood leakage was confirmed through image evaluation. Non-vented cap opaque appearance could not be confirmed through image evaluation due to leakage. In this case, the vent cap from the introducer was used on the side port of the optisite cannula resulting in blood loss and required a blood transfusion. The patient has been reported to be in stable condition. The subject device is not available for evaluation per the customer. The root cause remains indeterminable. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed. If any new information is received, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that the optisite arterial cannula was used for cannulation of the aortic during bypass. The cannula continued to "weep" from the side vent opaque cap. The patient lost a unit of blood and was given a unit of packed cells for a non-critical value, the patient was reported to be stable. There were no postoperative complications related to this event and the patient discharged to a rehabilitation facility. Additional information received: the opaque cap shown in the provided photo was present and attached to the cannula in the package. There was no white non-vented cap present in the packaging at all. It was noted that the hospital's older lots have a solid white non-vented cap. The cannula started weeping around the timing of the sewing of the second distal.
 
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Brand Name18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
12050 lone peak parkway
mle-2
draper, UT 84020
9492504062
MDR Report Key9377193
MDR Text Key168770264
Report Number3008500478-2019-00172
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2021
Device Model NumberOPTI22
Device Catalogue NumberOPTI22
Device Lot Number61338640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/26/2019 Patient Sequence Number: 1
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