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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03705PTS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 02/09/2022
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided the inspire 8f oxygenator is a non-sterile device assembled into a sterile convenience pack (item in01586, lot 2106250163) that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. The complained inspire 8f oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The standalone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k180448). The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled. Sorin group (b)(4) manufactures the inspire 8m hollow fiber oxygenator. The incident occurred in (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. According to the customer, theoretical flow rate on the remote roller pump was 4l. Flow rate measured with their scpc centrifugal flow sensor was 3 l/m. Medical team fear the use of 8f on large patients or dissections. During follow up with the customer it was confirmed that: - the claimed oxygenator is no longer available and - the purges lines of the inspire oxygenator were open at the time of detecting the different flow values. It shall be noticed that, in the ifu of the inspire 8f oxygenator, it is indicated if the purge lines are kept open when the main pump is running, this will generate spontaneous flow in the purge lines (paragraph j. Initiating bypass ¿ chapter 5- continuous air purge - spontaneous flow of purge/recirculation line @ 150 mmhg arterial line pressure and 6 l/min main pump blood flow, is approx. 620 ml/min with both purge lines open, 420 ml/min with pre filter purge line open and 420 ml/min with post filter purge line open. ) if any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) has received a report that, according to the perfusionist, when using an inspire 8f oxygenator, the blood flow value detected by the sensor of a scpc pump is lower than the one calculated by the arterial pump. The discrepancy is of 1. 5 l/m. The perfusionist elected to increase the pump flow to obtain a blood flow of 4l/m. The team informed livanova that they have noticed hematuria in the patient urine. There is no report of any patient injury.
 
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Brand NameINSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key13720953
MDR Text Key290454489
Report Number9680841-2022-00015
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 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03705PTS
Device Lot Number2106290087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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