MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL LILLIPUT 1 START; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050578

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, after the change out of the lilliput oxygenator, the second lillup oxygenator did not perform as expected.The procedure was a norwood.Patient was connected to ecmo at the end of the procedure.

Manufacturer Narrative

A.1., a.3, a.5.Patient information were not provided.D.4.The expiration date refers to the sterile finished product.The complained lilliput 1 start oxygenator (catalog number 050578) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050578 is similar to the lilliput 1 new born hollow fiber oxygenator catalogued 05319, which is distributed in the usa, for which the device identifier is (b)(4).G.5.The product item 050578 is not distributed in the usa and it is similar to the lilliput 1 new born hollow fiber oxygenator catalogued 05319, which is distributed in the usa (510(k) number: k953835).H.4.The device manufacture date refers to manufacture date of the sterile, finished oxygenator.H.10.Sorin group italia manufactures the lilliput 1 start oxygenator.The incident occurred in israel.The involved device has been requested for return to sorin group italia for investigation.Through follow up with the customer livanova learned the surgery lasted 5 hours.The gas-exchange performances of second oxygenator started to decrease about two hours from when it was installed.The patient was placed on ecmo (which was ready at the bedside) one minute after the end of the operation.The conversion was instantaneous.The patient had severe lv dysfunction at the end of the operation and could not be weaned from cpb, ecmo support was necessary.Norwood is the most critical situation on patient and is classified as a surgery with an high risk of mortality.In case of survive, the patient shall need a heart transplant at 8-12 year.Ecmo is typical ending of this type of cardiac surgery.No correlation between reported event and devices used.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Complained lilliput oxygenator units were returned and investigated at livanova.During the drying at preliminary wash steps (before actual test), foam was observed from the gas escape port of both units.Such a behavior is consistent with extended hydrophilization of the oxygenator fibers and plasma breakthrough in gas side which resulted in plasma leakage at customer's site, in line with the complained event.Conditions of returned devices did not allow to perform any further analysis of gas exchange performance.Dhr review confirm the device was released conforming to product specification.Analysis of livanova complaints database revealed no further similar cases affecting involved batch.No adverse trend for lilliput devices assembled with same item of fiber was registered.As confirmation, the customer already used 96 units of claimed lilliput oxygenator lot before these events and no similar case was experienced.A possible fiber raw material defect, associated with increased porosity of hollow fiber which let plasma to pour out of fiber thus creating a barrier to the passage of gas through fiber, can be excluded since no further similar event was recorded in last 24 months and no oxygenator assembled with same lot of fiber was complained by other customers.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: LILLIPUT 1 START
• 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; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16751639
• MDR Text Key: 313661785
• Report Number: 9680841-2023-00013
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 09/28/2023

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 Catalogue Number: 050578
• Device Lot Number: 2205270026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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 Sex: Male
• Patient Weight: 3 KG