MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 050526

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

The issue occurred prior to any patient involvement.The d731 micro 27 arterial filter is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the arterial filter was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).The involved d731 micro 27 arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone d731 micro 27 arterial filter is also registered in the usa (510(k) number: k112525).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the d731 micro 27 arterial filter was assembled.Sorin group italia manufactures the d731 micro 27 arterial filter.The incident occurred in morristown, united states of america.The involved device has been discarded.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device has been disposed by the customer.

Event Description

Livanova usa inc has received a report that, during priming of a circuit, particulate movable matter was noticed inside the d731 micro 27 arterial filter.The medical team has cut the filter out and replaced it with one from the inventory.The issue occurred prior to any patient involvement.

Event Description

See initial report.

Manufacturer Narrative

Livanova received a report stating that during priming a mobile whitish plastic particle was found inside the arterial filter.No picture or video was available, and the unit was discarded.During follow-up activity, it could not be established if the particle was located before or after the filter mesh.Involved lot of arterial filter was already complained by this same customer for similar issue.It cannot be ruled out that whitish particle was a welding flash reasonably resulting from the welding phase of the polycarbonate, from which the filter is made.The risk is in the acceptable region.No corrective action is deemed necessary.Livanova will keep monitoring the market.

• Brand Name: D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14432708
• MDR Text Key: 300258577
• Report Number: 9680841-2022-00025
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 050526
• Device Lot Number: 2105250145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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