MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 03497

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The d131 kids arterial filter is a non-sterile device assembled into a sterile convenience pack (lot 1708020063) 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.Two possible lots of d131 kids arterial filter have been identified 1705190156 and 1705050037.The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).The complained d131 kids arterial filter is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050542) is registered in the usa (510(k) number: k072308).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 d131 kids arterial filter.The incident occurred in (b)(6).Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and (b)(4).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 italia for investigation but not yet returned.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group italia has been informed that, 15 minutes after the begin of the extracorporeal circulation, a blood leak along the seam of the d131 kids arterial filter was identified.The medical team elected to decrease the patient temperature to 25°c.According to information, total blood loss was 800 to 1000 cc.The patient was transfused as a consequence of the blood loss.

Manufacturer Narrative

Visual inspection of the returned arterial filter found the o-silicone ring in the perimeter of the device partially misplaced.Leak test of the unit reproduced the claimed leak.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue: the unit positively passed the in-process leak test and visual inspection.No other complaint was recorded relevant to the complained lot.Laboratory test suggests the reported failure was related to the misplaced o-silicone ring, the misplacing of the o-ring was likely triggered after product release.Frequency of this type of event is very low (remote).No corrective action will be undertaken.Livanova will keep monitoring the market.

• Brand Name: D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8707026
• MDR Text Key: 200426877
• Report Number: 9680841-2019-00023
• 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
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 03497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Device Age: 22 MO
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 18