MAUDE Adverse Event Report: SORIN GROUP ITALIA D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 03497

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

Patient was not involved.The d131 dideco kids infant arterial filter is a non-sterile device assembled into a sterile convenience pack (lot 1511090048) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the arterial filter was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).The complained d131 dideco kids infant arterial filter is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone arterial filter (catalog number 050542) is registered in the usa.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the arterial filter was assembled.Sorin group (b)(4) manufactures the d131 dideco kids infant arterial filter.The incident occurred in (b)(6).(b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.This mdr has been already submitted july 10, 2018 and resubmitted due to missing 3rd acknowledgment.Device not available for return.

Event Description

Sorin group (b)(4) received a report that the blood outlet connector of the d131 arterial filter completely broke off during set-up.The issue occurred prior to patient involvement.

Manufacturer Narrative

Sorin group italia manufactures the d131 dideco kids infant arterial filter.The incident occurred in khartoum, sudan.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The device was discarded by the user.Basing on a photograph provided by the customer, the filter outlet connector was confirmed to be broken at the base of the connector itself.A review of the production history confirmed that the reported arterial filter lot was used for the manufacturing of numerous other circuits that were distributed all over the world.As of today, sorin group italia has not received any additional reports concerning the reported lot.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the device was not available for investigation, a root cause could not be established.However, based on the investigation for previously reported similar events, the potential cause of the event was determined to be the release of mold-in stresses enhanced by shipping transportation stresses.

• Brand Name: D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7689122
• MDR Text Key: 114557870
• Report Number: 9680841-2018-00018
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 03497
• Device Lot Number: 1510060162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2018
• Device Age: 31 MO
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1