MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D100 NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D100 PHISIO
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the kids d100 neonatal oxygenator.The incident occurred in (b)(6).The involved oxygenator is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Sorin group (b)(4) has received a report that, after 1 hour of usage during a procedure, the oxygen partial pressure was 60 mmhg.The procedure was completed.There is no report of any patient injury.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova received report about decreased blood oxygenation performance, at the end of a procedure, using a d100 kids oxygenator.The complained oxygenator was not available for investigation.Verification of the manufacturing records confirmed the oxygenator was released conforming to product specifications.Analysis of livanova complaint database did not identify any other similar related to the complained oxygenator thus excluding a systematic quality issue.On november 24th, 2021, the pump sheet and blood gas analysis of the event were provided to livanova.Available data showed that, when the fio2 was raised from 60% to 75%, the patient po2 did not improved.Therefore, the complained decreased oxygenation performance has been confirmed.Differently from what stated at the submission of the event, there is no evidence in the pump sheets that fio2 was raised to 100% and no evidence that po2 were 60 mmhg.Livanova believes that the most probable explanation of the decreased oxygenation performance was the presence of shunted area across the oxygenating fibers of the oxygenator.This was likely caused by undesired cellular activation inside the oxygenator associated with platelet adhesion and fibrin layer deposition within the oxygenator, due to specific characteristics of the patient blood.Since no device related malfunction could be confirmed, no corrective action was deemed necessary.Livanova will keep monitoring the market.H3 other text : not available.

• Brand Name: D100 NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 12916320
• Report Number: 9680841-2021-00039
• Device Sequence Number: 14864089
• Product Code: DTZ
• UDI-Device Identifier: 08033178100359
• UDI-Public: (01)08033178100359(17)230622(10)2006220190(11)200622(240)050531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: D100 PHISIO
• Device Catalogue Number: 050531
• Device Lot Number: 2006220190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown