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

Model Number 8F DUAL PH.I.S.I.O.

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, during an extra corporeal circulation procedure, at fio2 of 60% and gas flow at 2.50 l/min, the pao2 resulted 50.6 mmhg.Medical team increased the fio2 to 100% and the pao2 increased to 429 mmhg.Medical team decreased the fio2 back to 60% and the pao2 become 57.9 mmhg.Medical team re-increased the fio2 to 100% and the pao2 increased to 427 mmhg.Medical team decreased the fio2 to 80% and performance of the inspire oxygenator declined.During the warming phase, even though the fio2 was increased to 90%, the pao2 values were poor.There is no report of any patient injury.According to information, the day before the event, the oxygenator had been primed and recirculated for 3 hours.

Manufacturer Narrative

Sorin group italia manufactures the iinspire 8f dual hollow fiber oxygenator with integrated arterial filter.The incident occurred in perugiua, italy.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Verification of production records confirmed that noticed lot was released as conform according to specifications.Review of complaints database revealed no other similar issue notified for batch concerned from the market out of (b)(4) total manufactured units sold worldwide, this excluding a manufacturing deviation batch-related.Analysis of provided pump-sheet highlighted that the lowest values of arterial po2 (50,6 mmhg and 57,9 mmhg) were both measured against a fio2 percentage of 60%, with an average gas/blood ratio of 0.5.The resultant hemoglobin oxygen saturation percentage was below 90%.After raising fio2 percentages to 90-100% and gas/blood ratio to 0.7 level during troubleshooting, a significant improvement of the gas exchange performances was achieved since a po2 peak value of 429 mmhg was obtained this providing a hemoglobin oxygen saturation percentage above 99%.As stated within ifu's of the product, the suggested gas/blood flow ratio in normothermic conditions is 1:1 with a fio2 ranging from 80 to 100%.In addition, if low po2 values are measured in arterial line, ifu's of the product recommend to increase the fio2.In this case, decreased oxygenation levels were detected with a gas flow about half of the blood flow and fio2 set to 60%, while adequate gas exchange performances were restored after increasing fio2 and gas/blood flows ratio.All these elements lead to the conclusion that the oxygenator dynamic was found responsive to gas flow and concentration maneuvers applied during troubleshooting activity.Therefore, based on the above facts, it cannot be excluded that the most likely root cause of temporary low oxygenation condition was a multifactorial issue, resulting from the interaction between clinical procedure, patient conditions and gas-blood settings.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, 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 Key: 15922641
• MDR Text Key: 305256974
• Report Number: 9680841-2022-00058
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112420
• UDI-Public: (01)08033178112420(17)250615(10)2206160014(11)220616(240)050720
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K122844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8F DUAL PH.I.S.I.O.
• Device Catalogue Number: 050720
• Device Lot Number: 2206160014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1