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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOM; OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOM; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050719
Device Problem Air Leak (1008)
Patient Problem Stroke/CVA (1770)
Event Date 04/29/2016
Event Type  Injury  
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.The device is not available to return, as it was discarded by the user before learning the patient had a stroke.The customer reported that the bubble detector never detected air and the perfusionist does not believe any was delivered to the patient.Cerebral o2 monitoring was in use during the procedure and that stats were normal throughout the case, so the customer does not believe the patient's condition was in any way caused by the performance of the oxygenator.The patient is currently awake and alert and the condition is improving.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Device discarded by user.
 
Event Description
Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.Though the unit was discarded by the user and an investigation could not be performed, a video sent to sorin group (b)(4) by the customer showed that the device had been set up with a suction tube containing air from the operating field connected to the non-activated suction port of the reservoir.This setup is contrary to what is advised in the instructions for use (ifu).In order to minimize gaseous microemboli activity, the ifu recommends avoiding the infusion of any fluid mixed with air through the non-activated blood suction port of the reservoir.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The complained issue was classified as a rare event, as no other similar cases have been reported.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Video received, device discarded by user.
 
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Brand Name
INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOM
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola (mo), 41037
IT  41037
Manufacturer (Section G)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola, 41037
IT   41037
Manufacturer Contact
carrie wood
14401 w 65th way
arvada, CO 80004
3034676461
MDR Report Key5680785
MDR Text Key45958210
Report Number9680841-2016-00363
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/01/2016
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 Expiration Date07/08/2018
Device Catalogue Number050719
Device Lot Number1507080007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/01/2016
Initial Date FDA Received05/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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