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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number IN00159
Device Problem Fluid Leak (1250)
Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 04/22/2016
Event Type  Injury  
Manufacturer Narrative
The inspire 6f m hollow fiber oxygenator was assembled into a customized circuit, code (b)(4), that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510(k) number: k130209). Sorin group (b)(4) manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that a blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure. The origin of the leak could not be identified. The oxygenator and circuit were changed out to complete the procedure. The blood loss was estimated to be between 500ml and 1000ml. On may 3, 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support. 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 blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure. The origin of the leak could not be identified. The oxygenator and circuit were changed out to complete the procedure. The blood loss was estimated to be between 500ml and 1000ml. On may 3, 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support.
 
Manufacturer Narrative
(b)(4). Sorin group (b)(4) manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch is being filed on behalf of sorin group (b)(4). Soring group (b)(4) received a report that a blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure. The origin of the leak could not be identified. The oxygenator and circuit were changed out to complete the procedure. The blood loss was estimated to be beween 500ml and 1000ml. On (b)(6) 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support. The involved oxygenator was returned to sorin group (b)(4) for investigation. Visual inspection of the returned device identified a crack in the male luer. A leak test was performed at the maximum recommended pressure level, however the leak could not be reproduced. The purge line was stretched and the test was repeated, at which point a leak was observed between the male connector of the purge line and the female connector of the oxygenator, originating from the male luer. A simulation of excessive torque was performed, however the defect was not reproduced. Through further investigation, sorin group (b)(4) determined that the leak described by the customer was caused by a deformation inside the male connector, likely generated during molding. The occurrence rate for this type of issue is very low, however the supplier of the connector has been notified of the event. A review of the dhr was unable to identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
 
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Brand NameINSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
Type of DeviceOXYGENATOR, 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 (mo), 41037
IT 41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5668497
MDR Text Key45569354
Report Number9680841-2016-00305
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue NumberIN00159
Device Lot Number1602010136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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: 05/19/2016 Patient Sequence Number: 1
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