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

Catalog Number 03705

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, during priming, a piece of material moved from the oxygenator to the arterial line of the circuit.The issue occurred prior to any patient involvement.

Manufacturer Narrative

The issue occurred prior to any patient involvement.The inspire 8f oxygenator is a non-sterile device assembled into a sterile convenience pack (catalogue in02738h, lot 2111180124) 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 oxygenator item 03705 is similar to the item 050703 - inspire 8f hollow fiber oxygenator with integrated arterial filter, which is distributed in the usa, for which the device identifier is (b)(6).The complained inspire 8f oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The complained inspire 8f oxygenator is not distributed in the usa, but it is similar to the item 050703 - inspire 8f oxygenator which is distributed 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 oxygenator.The incident occurred in lille, france.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova has received a report stating that during priming, a foreign particle was noted in the arterial/venous line.No patient was affected.The customer has provided a photographic evidence showing the plastic substance.The complained circuit was returned to livanova for inspection.Visual inspection of the returned part confirmed the presence of foreign material in the arterial/venous line of around 12 mm.The foreign material was subjected to physical characterization through fourier-transform infrared spectroscopy (ft-ir) analysis and laboratory results showed a 97% spectra match with polyethylene.The material inside the complained reservoir is made of polyethylene.The dhr review of the complained lot confirmed the device was released conforming to product specifications.Review of the livanova complaint databased did not identify any other similar event relevant to the same circuit catalogue item code thus confirming this is an isolated event.Based on the above, it cannot be ruled out that the root cause of the reported event was assigned to isolated manufacturing deviation.In details, a manufacturing residue was accidentally released during the manufacturing process of the unit.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; FR 41037
• 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: 14710872
• MDR Text Key: 301744841
• Report Number: 9680841-2022-00027
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03705
• Device Lot Number: 2111190107 OR 2111190162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1