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

Model Number 03705PTS

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The complained inspire 8f oxygenator is a non-sterile device assembled into a sterile convenience pack (catalogue in00589) 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 complained inspire 8f oxygenator is similar to the inspire 8f oxygenator catalogue 050703, which is distributed in the usa, for which the device identifier is 08033178112284.The complained inspire 8f oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa and similar to the inspire 8f catalogue 050703, which is distributed in the usa (510(k) number: k180448).The device manufacturing date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group italia manufactures the inspire 8f.The incident occurred in barcelona, spain.Livanova is following up with the customer for additional information.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, when assembling the circuit for the procedure, before priming, the medical team observed leakage from the connections of the normo-hypothermia hoses to the oxygenator module.There was no patient involvement.

Event Description

See intial report.

Manufacturer Narrative

Based on manufacturing records, two possible lots of oxygenator 03705pts were assembled in the involved pts lot, which are the following: 2205110073 and 2205100087.Manufacturing records have been verified to be conforming to specifications.No other similar events have been identified for this pts pn or lot and for both oxygenator lots.Despite being requested, the item was not returned for investigation.No pictures or information regarding the precise leak location were provided.Based on available information and considering similar complaint investigations, it cannot be excluded that the reported event was due to a open channel between blood and water compartments due to damaged capillary in the distal portion of heat exchanger fibers.Considering that 100% of the units in production line is subjected to final leak test and that involved unit successfully passed the in-process check and no trend has been registered for similar case, it cannot be excluded that fiber bundle capillary manufacturing variability with contribution of sterilization thermal and/or transportation mechanical stress could have led to breakage during use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: INSPIRE 8F M
• 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: 15922647
• MDR Text Key: 305926908
• Report Number: 9680841-2022-00059
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/20/2023

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: 03705PTS
• Device Lot Number: 2205100087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1