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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

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SORIN GROUP ITALIA INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER Back to Search Results
Catalog Number 050716
Device Problem Medical Gas Supply Problem (2985)
Patient Problem Ischemia (1942)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Lot of the oxygenator has not been provided. Therefore, expiry date and udi are unknown. Lot of the oxygenator has not been provided. Therefore, manufacturing date is unknown. Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator. The incident occurred in (b)(6). On (b)(6) 2021, follow up information with the customer clarified the following points: the minimum po2 value reached during cpb was 55 mmhg. At the time of this measurement, blood flow was about 4. 2 lpm and fio2 was ranging from 60 to 80%. To improve gas exchange performance, tubing connections between gas-blender and oxygenator were changed, gas flow rate was raised to 8 lpm and fio2 to 100%. First blood-gas report taken after referred maneuvers revealed increased blood oxygenation levels since a po2 value of 494 mmhg. However, medical team elected to change-out involved oxygenator and took 3 minutes to carry out the replacement. Blood-gas flow settings were returned to baseline values (4,2-4,3 lpm blood flow, fio2 60-70%) and a po2 value of 317 was achieved. Surgery was completed with po2 values steadily kept above 280 mmhg. There was no impact on oxygenator performance in removing co2 from patient blood. Patient outcome: immediate post-surgery attempts to wake and extubate, failed. Dense left hemiplegia, right lower limb weakness ¿ eventually required tracheostomy. Slow respiratory wean, as a result. Continuing itu level care. On 24/06/2021, there are differential diagnoses of patient status: no evidence of bleeding. Rt hemisphere: low density changes with ischemic features in the occipital lobe (area pca), and others too. Low perfusion, substrate of ica stenoses. Mild microvascular changes. According to customer, central oxygen supply and all connections and circuits were checked. Tube, including filter, connecting blender and oxygenator changed at 11. 58h. Ventilation with a tidal volume of 200ml and 8lit flow (fio2
=
100%) was started at 11. 58h 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 of poor oxygenation during a procedure. No information of patient injury was reported.
 
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Brand NameINSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Type of DeviceOXYGENATOR
Manufacturer (Section D)
SORIN GROUP ITALIA
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 Key12206270
MDR Text Key266415366
Report Number9680841-2021-00018
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K180448
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 01/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number050716
Device Lot Number2011200157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2020
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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