MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE HARD VENOUS RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03717

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, during a procedure, insufficient breakthrough of the inspire hard venous reservoir.The filter media/screen inside the reservoir has resulted in post cannulation reservoir change outs with patient blood.There is no report of any patient injury.

Manufacturer Narrative

No patient information has been provided.The inspire hard venous reservoir is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa (item 046006107, lot 2206800030).The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).The involved inspire hard venous reservoir is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone reservoir (catalog number 050704) is also registered in the usa (510(k) number: k130433).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 hard venous reservoir.The incident occurred in knoxville, tennessee, united stated of america.The involved device is not available for return to sorin group italia for investigation if any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.

Event Description

See initial report.

Manufacturer Narrative

Livanova received a report of increased breakthrough time of the blood entering the venous return filter screen of inspire hard venous reservoir (hvr).Medical team elected to change-out the unit.There is no report of any patient injury.A video, provided by the customer, showed some turbulence in the patient venous blood (incoming blood).Despite attempts, no further details relevant to change-out procedure, patient clinical history and any additional medical intervention adopted to tackle the blood filtration issue were given.According to manufacturing procedure, 100% of the inspire hvr and the filter are phosphorylcholine coated to further reduce the blood activation during contact with external layers.At the end of the coating treatment, all units are visually checked to confirm absence of wet areas, deposits, opacity, or other defects.Dhr verification of the complained hvr lot confirmed that no deviations or non-conformities was identified during manufacturing process of involved unit.Review of livanova complaints database revealed another similar event from the same customer and related to the same lot of inspire hvr, out of 240 total manufactured units.Based on the above, the most likely root cause of complained hold up was an unexpected blood activation in the reservoir, resulting in the presence of biological deposits / clots in the bottom region of venous filter system that have partially occluded the filtering elements and concomitantly reduced of open surface that allows the blood to flow.The blood clotting issue is a multi-factorial phenomenon correlated with clinical procedure therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.Since the risk is in the acceptable region, no specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE HARD VENOUS RESERVOIR
• 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: 15091547
• MDR Text Key: 304633402
• Report Number: 9680841-2022-00031
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 03717
• Device Lot Number: 2110290097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2022
• 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