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

Model Number 03705

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.No patient information has been provided.D.4.The inspire 8m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The item and the lot of the convenience pack is pending.Therefore also the unique identifier (udi) number of the sterile convenience pack is pending.Information will be provided when avaialable.G.5.The involved inspire 8m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448).H.4.The item and the lot of the convenience pack is pending.Therefore also the manufacture date is pending.Information will be provided when avaialable.H.10.Livanova manufactures the inspire 8m hollow fiber oxygenator.The incident occurred in united states.The involved device has been requested for return to sorin group italia for investigation.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 received, it will be provided in a supplemental report.

Event Description

Sorin group italia has received a report that, during a procedure, blood was seen in the oxy/heater cooler connection area.Heater cooler was unhooked and blood was noticed leaking for input and output water connections of the oxy for heater cooler.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

D.4.The inspire 8m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The item and the lot of the convenience pack are 044052501 and 2314500059 respectively.The unique identifier (udi) number of the sterile convenience pack is (b)(4).The expiration date refers to the sterile finished product into which the oxygenator was assembled.H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.

• Brand Name: INSPIRE 8F M
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena)
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17359638
• MDR Text Key: 319481074
• Report Number: 9680841-2023-00029
• 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: 08/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 03705
• Device Lot Number: 2302200078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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