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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; OXYGENATOR, CARDIOPULMONARY BYPASS
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SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050714
Device Problem Increase in Pressure (1491)
Patient Problem Embolism (1829)
Event Date 11/18/2015
Event Type  Injury  
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that a pressure increase was seen in the inspire 8m hollow fiber oxygenator 45 minutes after starting the procedure and the oxygenator had to be changed.The patient showed post operative cholesterol embolism, but causality cannot be confirmed based on the current information from the customer.Attempts have been made to gather more information on the patient outcome but the facility has not disclosed any additional information.The investigation is on going.A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that a pressure increase was seen in the inspire 8m hollow fiber oxygenator 45 minutes after starting the procedure and the oxygenator had to be changed.The patient showed post operative cholesterol embolism, but causality cannot be confirmed based on the current information from the customer.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that a pressure increase was seen in the inspire 8m hollow fiber oxygenator 45 minutes after starting the procedure and the oxygenator had to be changed.The patient showed post operative cholesterol embolism, but causality cannot be confirmed based on the current information from the customer.Attempts have been made to gather more information on the patient outcome but the facility has not disclosed any additional information.The involved oxygenator was returned to sorin group (b)(4) for investigation.It could not be investigated since it was kept full of patient blood.The pump readouts were not made available by the facility, so no procedure data analysis was possible.The manufacturing records were reviewed, revealing that the oxygenator involved in the event was released compliant to manufacturer specifications.Although the frequency of this type of issue is low, sorin group (b)(4) has initiated a capa to investigate this type of issue.
 
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Brand Name
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola (modena), italy 41037
IT  41037
Manufacturer (Section G)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola (mo), 41037
IT   41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5332521
MDR Text Key34595629
Report Number9680841-2015-00657
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130433
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 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/09/2018
Device Catalogue Number050714
Device Lot Number1509090144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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