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

Catalog Number 03707PTS

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Sorin group (b)(4) has received a report that, at the end of a procedure, blood leakage at the connection of the 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.All documents available to me are attached to the form.The set was kept and stored in a blue bin and is available for collection for further examinations.

Manufacturer Narrative

Patient id, age, sex, weight and ethnicity: 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 (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 (b)(4) for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova received a report of blood leakage from temperature probe cavity of an inspire 8 oxygenator.The medical team elected to administer additional antibiotic therapy to the patient.The customer provided explanatory pictures showing presence of blood traces in the oxygenator temperature probe cavity and onto the temperature probe pin (that was inserted in the cavity).Review of the livanova complaints database revealed one additional relevant to the same oxygenator lot.Internal investigation identified that the most probable root cause of leak is incomplete mold of the temperature probe connector.To prevent reoccurrence, a balancing of all cavities used to mold the temperature probe connector has been performed.The lot of the defective temperature probe connector was manufactured before implementation of the above described balancing.Since the risk is in the acceptable region, no additional corrective action is deemed necessary.Livanova will keep monitoring the market the complained oxygenator was declared available for investigation and thus requested for investigation.However, the oxygenator has not yet been returned for to livanova.It was concluded that the provided pictures and the similarity with other events was sufficient to complete the evaluation of the case.In the case the oxygenator will be returned, it will be investigated.In case of new finding, the event report will be updated.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR
• 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: 13415454
• MDR Text Key: 288037506
• Report Number: 9680841-2022-00010
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03707PTS
• Device Lot Number: 2108310137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG