MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D901 LILLIPUT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D901 + ADAPTORS
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group (b)(4) has received a report that, during a procedure, arterial blood sample could not be obtained from the arterial sampling port of two d901 lilliput oxygenators.Medical team elected to change out the oxygenators.The procedure was completed with no issue.There is no report of any patient injury.
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the d901 dideco lilliput oxygenator.The incident occurred in (b)(6).During follow up with the customer, livanova was informed that: change-out of the oxygenator took about 5 mins.The issue occurred at the very beginning of the by-pass.There was no impact on patient health.The involved devices 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.
Additional Manufacturer Narrative
Livanova received a report about no blood flow condition through arterial sampling port of lilliput d901 oxygenator during procedure.No patient / user impact occurred.Two units affected.Parts were not made available for return.Through follow-up communication, livanova learned that no change-out of the units was conducted.Perfusionist overcame the problem by taking arterial sample for blood-gas analysis from other points along the arterial line.Review of complaints database revealed no further similar case notified for batch concerned from the market.Based on investigation of previous similar events, the most probable root cause of the event is a suboptimal coupling of (i) the insert with membrane silicone valve and of the (ii) sampling line with the oxygenator port after the insert is manually positioned above the valve.Livanova has opened a non conformity report to further investigate the root cause and possible corrective actions.The risk is acceptable.Livanova will maintain monitoring the market.

• Brand Name: D901 LILLIPUT 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: 12909895
• Report Number: 9680841-2021-00038
• Device Sequence Number: 5085157
• Product Code: DTZ
• UDI-Device Identifier: 08033178100274
• UDI-Public: (01)08033178100274(17)220219(10)1902200119(11)190220(240)05318
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 02/19/2022
• Device Model Number: D901 + ADAPTORS
• Device Catalogue Number: 05318
• Device Lot Number: 1902200119
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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