MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 START P; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 050712

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.D.4.The expiration date refers to the sterile finished product.The complained inspire 8 start p oxygenator (catalog number 050712) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050712 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(6).G.5.The product item 050712 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433).H.4.The device manufacture date refers to manufacture date of the sterile, finished oxygenator.H.10.Sorin group italia manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in germany.The involved device has not been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Soring group italia received a report a leak was seen from the insire oxygenator temperature probe.Medical team elected to change-out the oxygenator.There is no report of any patient injury.

Manufacturer Narrative

H10: despite requested, no further details related to the duration and surgical phase of oxygenator change out was obtained.No visual evidence showing the defect was provided.However, based on investigation results of a previous similar complaints analysis, it is reasonable to conclude that blood drops poured out of the inside of temperature probe connection holder.In details, investigation found a sub-optimal interference between the inner metal pin and the co-molded abs polymer thus causing the drop by drop leak.To further reduce the occurency, the temperature probe connection holder are sorted before assembly.Analysis of livanova complaints database revealed no other analogue case notified for batch concerned of oxygenator from the market.Dhr verification confirmed that noticed device was manufactured before above mentioned sorting.Investigation is on-going to identify adequate corrective actions.These type of issue causes negligible blood loss and therefore 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 8 START P
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 80309 ; IT 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17884296
• MDR Text Key: 325070778
• Report Number: 9680841-2023-00037
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 050712
• Device Lot Number: 2302270167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• 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