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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 7M HOLLOW FIBER OXYGENATOR

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SORIN GROUP ITALIA SRL INSPIRE 7M HOLLOW FIBER OXYGENATOR Back to Search Results
Catalog Number 050726
Device Problem Increase in Pressure (1491)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/22/2021
Event Type  Death  
Manufacturer Narrative
Patient information were not provided. The expiration date refers to the sterile finished product. The complained inspire 7 start oxygenator (catalog number 050726, lot 2104290006) is not distributed in the usa, therefore the udi is not applicable. The oxygenator item 050726 is similar to the inspire 7 oxygenator 050725, which is distributed in the usa, for which the device identifier is (b)(4). The product item 050726 is not distributed in the usa, but it is similar to the inspire 7 oxygenator item 050725, which is distributed in the usa (510(k) number: k190690). The device manufacture date refers to manufacture date of the sterile, finished oxygenator. Sorin group (b)(4) manufactures the inspire 7 start hollow fiber oxygenator. The incident occurred in (b)(6). The involved device has been requested for return to sorin group (b)(4) for investigation and received on 23/08/2021. The device has been sent to gamma ray decontamination on 31/08/2021, as per livanova procedure. During follow up with the customer, following information were received: event occurred on (b)(6) 2021 and patient died on (b)(6) 2021 patient had critical clinical history. On-going surgery was an aortic arch replacement (redo surgery). Three different by-pass times have been identified, change-out of the oxygenator was likely done during first by-pass time. No decay in overall gas exchange performances of the unit/s has been identified. Act times were maintained below 450 seconds during by-pass. Pump sheet has been received at livanova. Device under investigation in correlation with pump sheet information. In accordance with medical assessment performed by livanova clinical team, the reported low performance is well known issue reported in literature due to platelets adhesion. Oxygenator replacement is requested in case of low performance and in the reported event the replacement has not been performed. 3 bypass occurred during surgery and time between each other is quite long and could increase the adhesion. The reported clinical condition was very critical surgery with high risk of mortality. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) has received a report that, at the begin of an extra-corporeal circulation procedure, progressive increased transmembrane pressure was observed during use of an inspire 7 start p oxygenator. According to customer, also a decrease of oxygenator performance was observed. The patient died on (b)(6) 2021.
 
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Brand NameINSPIRE 7M HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola
Manufacturer (Section G)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer Contact
enrico greco
14401 w 65th way
arvada, CO 80004
MDR Report Key12420000
MDR Text Key269720641
Report Number9680841-2021-00025
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number050726
Device Lot Number2104290006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
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: 09/03/2021 Patient Sequence Number: 1
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