MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8F M; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 03705PTS

Device Problems Gas Output Problem (1266); Unexpected Therapeutic Results (1631)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.No patient information has been provided.D.4.The inspire 8f m hollow fiber oxygenator with integrated arterial filter oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).G.5.The involved inspire 8f m hollow fiber oxygenator with integrated arterial filter oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H.10.Sorin group italia manufactures the k180448.The incident occurred in france.Current state of the patient: no clinical consequences on the patient because immediate treatment by the healthcare team.Actions taken in the healthcare establishment for patient care: increase in o2 flow.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova has received a report that there was a desaturation in the arterial line despite supplying the oxygenator with o2.The issue occurred when starting cec.There was no patient injury.

Event Description

See intial report.

Manufacturer Narrative

Increase the fio2 level is the solution recommended by ifu if low po2 values are measured in the patient's arterial blood, therefore it can be concluded that device responded properly to the applied countermeasure.No device malfunction was confirmed accordingly.Review of livanova complaints database identified no further similar cases notified for concerned batch, out of (b)(4) total manufactured units, thus a systematic quality issue can be excluded.No adverse trend related to this issue has been identified either.Despite several attempts performed, no additional information about blood gas values, initial flow settings, detailed troubleshooting and duration of low oxygenation condition was provided.Based on limited data available, the specific root cause of the reported event could not be clearly determined.If any additional information pertinent to the reported event and impacting the investigation results is received, this complaint file will be re-opened and updated.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 8F M
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 18433541
• MDR Text Key: 331790000
• Report Number: 9680841-2024-00001
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Public: (01)(17)240605(10)2310100231(240)03705PTS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03705PTS
• Device Lot Number: 2310100231
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1