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

Model Number 8F PH.I.S.I.O.

Device Problems Fluid/Blood Leak (1250); Increase in Pressure (1491)

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

Event Type  malfunction  

Manufacturer Narrative

Event date is unknown.Device is not available for investigation.Sorin group italia manufactures the inspire 8f oxygenator.The incident occurred in egypt.Follow up with the customer clarified the following points: the pump sheet of the case is not available.Oxygenator was changed-out during aortic cross-clamp and change-out lasted more than 3 minutes.Nearly 300 ml of patient blood were loss.There is no other patient impact.The oxygenator inlet tubing connection that leaked was secured with a tie band.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.

Event Description

Sorin group italia has received a report that, during a procedure, the transmembrane pressure across an inspire 8f oxygenator increased causing leakage.Medical team elected to change-out the oxygenator.The procedure was prolonged.Patient impact is blood loss.

Manufacturer Narrative

Livanova received a report stating that an inspire oxygenator increase transmembrane pressure during a surgery and oxygenator inlet port disconnected.Medical team elected to change-out the oxygenator.Complained oxygenator was disposed by the customer and thus is no available for investigation.Verification of manufacturing records confirmed that involved device was released as conform according to specification.Analysis of complaints database revealed no other similar cases notified for batch concerned.No pump sheet (including all the perfusion data) was provided by the customer.Thus, no analysis of the event at customer's site in terms of pressure excursion could be done.Livanova it is reasonable to consider the increased transmembrane pressure associated to an undesired cellular activation and consequent increase of biological material inside circuit as a result of platelet adhesion and fibrin layer deposition in oxy fibers.High pressure excursion event across oxygenator is a multifactorial phenomenon possibly affected by interaction of multiple contributing factors such as clinical procedure (e.G.Surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions.The risk is in the acceptable region.No corrective action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: INSPIRE 8F 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: 14306936
• MDR Text Key: 299690271
• Report Number: 9680841-2022-00024
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)240804(10)2108060131(11)210806(240)050716
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K130433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 2108060131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG