MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050710

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, at the beginning of a cec with temperature of 36°c, after purging the cardioplegia, no flow could be achieved.Medical team elected to change-out the oxygenator.There is no report of any patient injury.

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 8 start oxygenator (catalog number 050710, lot 2108240165) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050710 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4).Pma/510k.The product item 050710 is not distributed in the usa and it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Device manufacture date.Sorin group italia manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).The involved oxygenator is available and has not been requested.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

During follow up with the customer, livanova was informed that the changeout took less than one minute, so that it could pass blood volume, the heart was massaged while it was being carried out.

Event Description

See initial report.

Manufacturer Narrative

Medical team elected to change-out the device and procedure was completed without any patient impact.The changeout takes less than one minute, so the event has been reassessed as not reportable.However, an initial report to fda was already submitted, therefore, a follow up has been triggered.The oxygenator was returned to manufacturer for product analysis: the reported event was not reproduced and device was found to be properly working as per design specification with no deviation identified.Analysis of provided pump-sheet could not be performed since no all the relevant data were made available.No further similar complaints have been recorded for noticed product lot on a total of 144 manufactured units worldwide distributed, thus excluding any systematic quality problem.Manufacturing records have been verified to be conforming to specifications.Based on historical data analysis, the high transmembrane oxygenator pressure gradient is related to the increase of hydraulic resistance as a result of undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator.This type of event is a multi-factorial phenomenon possibly triggered by a combination of clinical procedure, therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR
• 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: 14828581
• MDR Text Key: 301636017
• Report Number: 9680841-2022-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050710
• Device Lot Number: 2108240165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Male