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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 8 DUAL PH.I.S.I.O.
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Air Embolism (1697)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
On 21 october 2021, sorin group (b)(6) has received a report that, a customer noticed the presence of foam in the arterial line of an ispire oxygenator. There was no report of any patient injury. On 28 october 2021, sorin group (b)(6) has received a report the customer submitted to italian ministry of health and was informed that air was found also in the cannula. The medical team elected to re-cannulate the patient and the cec time was prolonged. On 16 november 2021, sorin group (b)(6) has been informed the patient has died.
 
Manufacturer Narrative
Patient information were not provided. Sorin group italia manufactures the inspire 8 dual. The incident occurred in varese, italy. Follow up clarification with the customer are on-going. The involved device has been requested for return to sorin group italia for investigation. According to additional information provided during follow-up activity with pharmaco-vigilance department of hospital, livanova learned that: there was no delayed surgical time. Pump sheet has been made available. Air/foam was noticed inside arterial line after aortic declamping during aortic contropulsator insertion. Debubbling phase was successfully carried out when priming the circuit. Death of patient was reported. No emptying of the reservoir was observed/conducted. Unit is available for return and testing. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. : device not yet received.
 
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Brand NameINSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA SRL
strada statale 12 nord, 86
mirandola, modena
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 Key12868339
MDR Text Key281198416
Report Number9680841-2021-00032
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier08033178112406
UDI-Public(01)08033178112406(17)240802(10)2108040002(11)210804(240)050718
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K121229
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 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8 DUAL PH.I.S.I.O.
Device Catalogue Number050718
Device Lot Number2108040002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
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: 11/24/2021 Patient Sequence Number: 1
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