MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050540J

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The complained d101 kids hollow fiber oxygenator (catalog number 050540j, lot 1608250105) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050540j is similar to the d101 kids oxygenator 050540, which is distributed in the usa, for which the device identifier is (b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The product item 050540j is not distributed in the usa, but it is similar to the d101 kids oxygenator 050540, which is distributed in the usa (510(k) number: k072091).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the d101 kids hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).The involved reservoir has been requested for return to sorin group (b)(4) for investigation.The reservoir was assembled into a customized perfusion tubing circuit by a non-sorin assembler in (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(4) received a report that the reservoir blood-outlet connector of the d101 kids hollow fiber oxygenator was hit and it was completely broken off during debubbling of the circuit.The issue occurred before use during set-up and priming.

Manufacturer Narrative

Sorin group italia manufactures the d101 kids hollow fiber oxygenator.The incident occurred in fuchu, japan.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and sorin group usa., inc.(importer).Inspection of the returned reservoir confirmed the blood out connector completely separated in two parts.No manufacturing defect nor dimension defect could be identified in the returned reservoir.The tube assembled to the reservoir was a non-sorin tube assembled by a non-sorin assembler in japan.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As no device issue could be identified and this is the unique case in the last 12 months, no corrective action is deemed necessary.Livanova will keep monitoring the market for similar events.

• Brand Name: D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8072849
• MDR Text Key: 128729447
• Report Number: 9680841-2018-00030
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: 050540J
• Device Lot Number: 1608250105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2018
• Device Age: 27 MO
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1