MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

Catalog Number 03705

Device Problem Increase in Pressure (1491)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 8f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00983 de bad neustadt) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained inspire 8f m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The standalone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k180448).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group italia manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in bad (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

The inlet pressure increase after about 1h over 600mmhg; pump stops; delta p was 550mmhg, customer change to a other hlm.

Event Description

See intial report.

Manufacturer Narrative

Livanova received report of high-pressure excursion event developed across inspire oxygenator 8f during surgery.Medical team elected to change-out the device (operation lasted more than 3 minutes) and procedure was completed without any patient impact.Manufacturing records were verified, and complaint history was reviewed: claimed device was released as conform according to specifications and no further similar issues were ever reported for batch concerned out of 240 total manufactured units sold worldwide, this excluding a systematic quality problem lot-related.Involved unit was returned to livanova facility for investigation after decontamination process.The device was found clogged, with visible traces of blood inside fiber bundle.To remove observed traces, blood compartment was gently flushed with demineralized water and dried with compressed air.During rinsing phase, thick blood was ejected from purge and arterial outlet ports.Upon completion of washing phase, functional test with bovine blood was carried out.Claimed device was tested as per design specifications: according to test results, returned unit was found to be properly working without any performance deviation identified.The measured p values were aligned with the acceptable range of values prescribed within product specifications as per reported blood parameters test conditions based on investigation results, any product malfunction was excluded.The necessary cleaning of the unit prior to functionally testing the device in livanova laboratory most likely removed any cellular deposition and thus restored it to pre-clinical conditions.The claimed high transmembrane oxygenator pressure gradient, not reproduced during lab testing but confirmed by pump-sheet analysis, was reasonably assigned to the increase of hydraulic resistance as a result of undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenators.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.The risk in the acceptable region.No specific action was currently deemed necessary.Livanova will maintain monitoring the market.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 11692551
• MDR Text Key: 265360329
• Report Number: 9680841-2021-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/26/2024
• Device Catalogue Number: 03705
• Device Lot Number: 2102030001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 130