MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050702J

Device Problem Increase in Pressure (1491)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Expiration date: the expiration date refers to the sterile finished product.The complained inspire 6f m hollow fiber oxygenator with integrated arterial filter (catalog number 050712j) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050712j is similar to the inspire 6f m hollow fiber oxygenator with integrated arterial filter oxygenator item 050702, which is distributed in the usa, for which the device identifier is (b)(4).The complained inspire 6f m hollow fiber oxygenator with integrated arterial filter (catalog number 050712j) is not distributed in the usa and it is similar to the inspire oxygenator 050702, which is distributed in the usa (510(k) number: k180448).Device manufacture date: the device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group italia manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter.The incident occurred in japan.The involved oxygenator has not yet been received at sorin group italia.The review of the dhr of 16s14638 could not identify any deviations or nonconformities relevant to the issue.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet received.

Event Description

Sorin group italia has received a report that, three (3) hours after the start of the procedure for taa (type ii), scp was resumed.However, the pressure inside the insipire oxygenaotr in use increased and was not possible to establish circulation.The medical team elected to change-out the oxygenator.Livanova was not informed of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

On (b)(6) 2023, livanova was informed that the patient's arterial deviation was extensive, and the procedure was divided into upper and lower extremities, and the event occurred during the procedure for the upper extremity.After 3 hours from the beginning of the procedure (15.49) the selective cerebral perfusion (scp) was resumed.At 19.00, rpm was increased to 2509, and high pressure (p_in and p_out) occurred.The circuit had shown no deviations, only when the procedure was resumed (setting 2509 rpm) the high pressures at the oxy inlet and outlet were noticed.Thus, the oxy was changed in less than 3 minutes after the aorta cross-clamp.Dhr review: design history files highlighted that the involved inspire oxy lot was released as conforming according to specifications, thus assuring product performance by means of fiber and pressure sealing integrity quality controls.As per the above, the event shall be assessed as not reportable since the change-out took less than 3 minutes.In fact, livanova considers a threshold of 3 minutes of interruption of perfusion as an event reportability decision factor.Events alleging interruption of procedure shorter than 3 minutes will be considered as presumptively not reportable clinical events.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 6F M 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: 16136479
• MDR Text Key: 307088350
• Report Number: 9680841-2023-00001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050702J
• Device Lot Number: 2209290004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• 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