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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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SORIN GROUP USA AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number RV-41032
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided.Sorin group received a report that during the procedure, after the rv-41032 cannula was set up, air was found inside the cannula.The device was removed and replaced with another rv-41032 cannula.After the device was removed, a split was found in the venous cannula.The patient outcome has not been provided.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Device discarded by user.
 
Event Description
Sorin group received a report that during the procedure, after the rv-41032 cannula was set up, air was found inside the cannula.The device was removed and replaced with another rv-41032 cannula.After the device was removed, a split was found in the venous cannula.The patient outcome has not been provided.
 
Manufacturer Narrative
Sorin group received a report that during the procedure, after the rv-41032 cannula was set up, air was found inside the cannula.The device was removed and replaced with another rv-41032 cannula.After the device was removed, a split was found in the venous cannula.There was no patient injury.Photographs provided by the customer showed a split in the tube of the right angled venous return cannula at the right angled bend.No product was returned for evaluation.Without the complaint product for an in-depth evaluation, the specific cause for this split in the cannula tube cannot be determined.The above revisions address over-heating of the product during the bending process.No trend was identified for this type of issue.This is the first complaint against this catalog number.Sorin group will continue to monitor for future recurrence.
 
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Brand Name
AORTIC ARCH CANNULA
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA
14401 w. 65th way
arvada CO 80004
Manufacturer (Section G)
SORIN GROUP USA, INC.
14401 w. 65th way
arvada CO 80004
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5542539
MDR Text Key41717924
Report Number1718850-2016-00171
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K943934
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2018
Device Model NumberRV-41032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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