MAUDE Adverse Event Report: SORIN GROUP ITALIA LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 05319

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, during a procedure, there was a loose piece in the venous reservoir.Medical team elected to change out the entire system.There is no report of any patient injury.

Manufacturer Narrative

Patient information were not provided.Livanova manufactures the lilliput 1 new born hollow fiber oxygenator.The incident occurred in brazil.Follow-up was initiated to get confirmation about duration of product change-out and relevant surgical phase when it was conducted.No detailed information was provided about oxygenator replacement.Pictures of the loose piece were taken by customer and made available for investigation, but quality of the images was very poor and no definitive conclusion about the type and source of complained particle could be reached.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow-up communication with the customer, livanova was informed that sample was discarded after the case and no identification of the piece inside the reservoir was performed.Involved device was replaced with another lilliput d901 oxygenator and the procedure went ahead without any further issue.The patient evolved well, with no complications related to the finding inside the reservoir.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Pictures of the floating piece (white mass) were taken by customer and made available for investigation, but quality of the images was very poor and no definitive conclusion about the type and source of complained particle could be reached.Review of livanova complaints database showed no other similar issue notified for batch concerned from the market, out of (b)(4) total manufactured units all distributed to india and brazil customers.Without the sample to be investigated, no ftir analysis could be run at livanova facility to characterize and identify involved material.Taking into account the available information, it cannot be ruled out that complained particle was most likely a biological aggregate (platelet mass entrapped in a fibrin network resulting from activation of blood coagulation).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18056060
• MDR Text Key: 327172580
• Report Number: 9680841-2023-00040
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100380
• UDI-Public: (01)08033178100380(17)250131(10)2202010101(240)05319
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K953835
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05319
• Device Lot Number: 2202010101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• 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