MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D901 + ADAPTORS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group (b)(6) received a report that, during priming of the water compartment, a leak was observed from the lilliput oxygenator.During follow up with the customer, sorin group (b)(6) has received a video that did not clarify if water entered the reservoir when priming the water side of lilliput oxygenator.The event occurred prior to any patient involvement.
Additional Manufacturer Narrative
Issue occurred prior to any patient involvement.Sorin group (b)(6) manufactures the lilliput 1 new born hollow fiber oxygenator.The incident occurred in (b)(6).During follow up with the customer, livanova has received a video showing the reported failure.Visual inspection of the provided video did not clarify if water entered the reservoir when priming the water side of lilliput oxygenator by means of dedicated holder.Therefore, a possible communication between water and blood sides cannot yet be completely ruled out.The oxygenator is available and has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet received.
Additional Manufacturer Narrative
Verification of the manufacturing record of the complained lot of lilliput oxygenator confirmed the oxygenator was released conforming to product specifications.Review of the livanova complaints database confirmed no other similar event relevant to the complained lot of oxygenator thus excluding any systematic issue.Visual inspection of the returned lilliput oxygenator did not identify any evident damage of the heat exchanger module.Functional test of the returned oxygenator did not reproduce any leakage for/through the heat exchange compartment: the device behaved as expected.Based on investigation results, it cannot be excluded that leakage event faced by customer was due to any of the following or by a combination of the following root causes: (i) defective lilliput holder, (ii) wearing of the o-rings of the lilliput holder, (iii) incorrect assembly of the oxygenator with the holder.Since the issue is not lilliput oxygenator related, no corrective action is deemed necessary.Livanova will keep monitoring the market for similar events.Based on available information, the event has been reassessed as not reportable.

• Brand Name: LILLIPUT 1 NEW BORN HOLLOW FIBER 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: 13340623
• Report Number: 9680841-2022-00007
• Device Sequence Number: 14432995
• Product Code: DTZ
• UDI-Device Identifier: 08033178100274
• UDI-Public: (01)08033178100274(17)230723(10)2012150090(11)201215(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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: D901 + ADAPTORS
• Device Catalogue Number: 05318
• Device Lot Number: 2012150090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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