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

Model Number 03707PTS

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, at the end of a procedure, blood leakage at the connection of the inspire oxygenator temperature probe was seen.The oxygenator was not changed out.There is no report of any patient injury.The medical team elected to administer additional antibiotic therapy.

Manufacturer Narrative

Patient information was not provided the inspire 8 m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in01478, lot 2108060076) 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 8m 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 050701) 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 8m hollow fiber oxygenator.The incident occurred in bad (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 received at sorin group italia for investigation and sent to decontamination.As per additional information provided: the patient did not suffer any consequences caused by the set.The leak was only discovered when the hlm was dismantled.Thus, blood loss was minimal and changing sets during the procedure was not indicated.In the further course, the patient was prophylactically covered with antibiotics.However, he showed no signs of impairment of the clinical outcome.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

The complained inspire 8 oxygenator was returned to livanova.Visual inspection of the returned oxygenator found dried blood in the inner core of white temperature probe housing thus confirming the reported condition.No crack along the holder connector body was detected.Therefore, external leakage was excluded.The temperature probe holder was marked with a ¿3¿ suggesting it was molded from cavity 3 of the mold.Review of the livanova complaints database did not identify any other similar event related to the complained oxygenator lot out of 180 units distributed worldwide.Dhr verification found the lot of the temperature probe connector was object of an internal investigation triggered by increased leaking rate.The investigation found that, due to a mold balancing issue, the cavity 3 of the mold was not correctly filled thus causing incomplete mold of the connector and eventually the reported leakages.To prevent reoccurrence, a mold balancing activity has been completed.The lot of the complained temperature probe connector was manufactured before above-described mold balancing activity.Since the risk is in the acceptable region, no other corrective action is deemed necessary.Livanova will keep monitoring the market.

Manufacturer Narrative

Following receipt of the unit, it was indentified the lot of the complained oxygenator which is 2109140172 (not 2108310137 as previously communicated).The oxygenator was assembled into a convenience pack that is not distribuited in usa.Review of complaints database revealed one further similar event notified from the market related to the oxygenator lot.The present follow up is being submitted to provide the above correction.

Event Description

See initial 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
• 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: 13632974
• MDR Text Key: 290457629
• Report Number: 9680841-2022-00012
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 03/03/2023

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 Expiration Date: 08/04/2024
• Device Model Number: 03707PTS
• Device Lot Number: 2108310137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 04/01/2022; 02/07/2023
• Supplement Dates FDA Received: 04/21/2022; 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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