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

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.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR
• 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 Key: 12206270
• MDR Text Key: 266415366
• Report Number: 9680841-2021-00018
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K180448
• Number of Events Reported: 1
• 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 Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 050716
• Device Lot Number: 2011200157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial