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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 IN00396
Device Problem Increase in Pressure (1491)
Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 05/06/2016
Event Type  Injury  
Manufacturer Narrative
No patient information were provided. The unit has not yet been returned to sorin group (b)(4). The inspire 6f m was assembled into a customized circuit (item (b)(4)) that is not distributed in the usa, but the oxygenator is similar to the inspire 6f m that is distributed in the usa (510k#: k120185). 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 two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood. The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful. The procedure was stopped in order to replace the oxygenator. The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali). The patient is awake but has not been discharged from the hospital. The oxygenator and tubing are delivered to the customer as separate parts, and the connection between the oxygenator inlet and the corresponding tubing is made by clinical personal. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is on-going. A follow-up report will be sent when the investigation will be completed.
 
Event Description
Sorin group (b)(4) received a report that two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood. The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful. The procedure was stopped in order to replace the oxygenator. The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali). The patient is awake but has not been discharged from the hospital.
 
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 two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood. The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful. The procedure was stopped in order to replace the oxygenator. The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali). The current patient status is unknown. The oxygenator and tubing are delivered to the customer as separate parts, and the connection between the oxygenator inlet and the corresponding tubing is made by clinical personal. Despite several attempts made by sorin group (b)(4) to retrieve information regarding the patient status and to have the involved unit returned for investigation, the hospital has not disclosed any new information, nor provided the device for investigation. Without the ability to investigate the unit, sorin group (b)(4) cannot determine a root cause or identify corrective actions. Such a connection was performed by the clinical personal and it cannot be excluded that the tubing was incorrectly fit onto the blood-inlet connector. 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 (modena), 41037
IT 41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5707764
MDR Text Key46853837
Report Number9680841-2016-00376
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
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 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Catalogue NumberIN00396
Device Lot Number1510230018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2015
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: 06/08/2016 Patient Sequence Number: 1
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