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

Catalog Number 03705

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

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 in00238; lot 1907030098) 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.Pma/510k: 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 (b)(6).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 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.

Event Description

Sorin group italia has received a report that, during a procedure, clotted blood was identified by the perfusionist around the arterial filter portion of the inspire oxygenator.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10 the hospital declared that the oxygenator was available for investigation.Livanova has requested the device back several times and it has not been provided.No investigation on the device could be performed.A review of the dhr did not identify any information relevant to the reported failure.As per the evidences collected, the root cause of the clotting failure experienced by customer is related to undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator.Based on medical literature, the origin of the activation and interaction appears to be not device related and to be multi-factorial in nature including patient status and clinical procedure.The event could not be traced to any device-related malfunction.No specific corrective action could be identified.Livanova will keep monitoring the market.Device requested but not returned.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9217453
• MDR Text Key: 216686330
• Report Number: 9680841-2019-00036
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Catalogue Number: 03705
• Device Lot Number: 1906260273
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1