MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL LILLIPUT HOLLOW FIBER OXYGENATOR D902; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number D902 PH.I.S.I.O.

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that, 4 lilliput oxygenators leaked from oxy site when connected to the heater cooler (1 unit lot 2002260217 and 3 units lot 2002260216).During follow up with the customer, sorin group (b)(4) has received that did not clarify if water entered the reservoir when priming the water side of lilliput oxygenators.The events occurred prior to any patient involvement.

Manufacturer Narrative

Pt info.Issue occurred prior to any patient involvement.Event date is unknown.Sorin group (b)(4) manufactures the d902 dideco lilliput phisio oxygenator.The incident occurred in (b)(6).On 03rd december, 2021 livanova has been informed that 3 or 4 lilliput oxygenators leaked from oxy site when connected to the heater cooler.This issue was occurred with 3 to 4 oxygenators as well.During follow up with the customer, on 20th december, 2021, livanova has received a video showing the reported failure.In addition, according to the perfusionist, the holder was double checked but no issue was identified.On 30th december, 2021, livanova received the full traceability of the 4 affected units: 1 unit lot 2002260217 and 3 units lot 2002260216.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.Livanova has recorded an additional complaint to keep trace also of the other three (3) units showing the same failure mode.All event will be reported.The oxygenators are available and have been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.

Manufacturer Narrative

Livanova received a report of water leak between the lilliput d902 oxygenator and the dedicated holder during priming of the oxygenator water compartment.At the submission of the case, a video was provided, and the leakage is confirmed based on the provided evidence.The customer has reported in total 4 events from 2 different oxygenator lots.In addition, the customer confirmed that 3 different lilliput holders were cross-checked after the events and no issue could be seen.It was not confirmed whether the same holder was used during the priming of complained units.Verification of manufacturing records pointed out that all oxygenator units were released as conform according to specifications.Analysis of the livanova complaints database revealed no other similar issues notified for batches concerned from the market.Complained units were declared available for investigation and were requested for investigation.However, during follow-up activity, livanova learned the unit return process from customer facility is currently blocked due to livanova unrelated problems.At the moment, unit return cannot be confirmed.Based on investigation of previous events, the reported issue could be due to: (i) damage in the heat exchanger metal sheet, allowing the passage of fluid from oxygenator water compartment to blood compartment.However, in the video provided by the customer, no fluid could be detected in the blood compartment of the oxygenator.(ii) damage of the o-rings of the holder(s) thus allowing fluid to leak in between the holder and the oxygenator.However, the customer reported the holders did not present any obvious problem.(iii) incorrect manual assembly of the oxygenator with the dedicated holder by user livanova believes the most probable root cause was an incorrect assembly.However, the other root causes could not be completely ruled out.If the complained units will be received, they will be investigated.In the case of new findings, event record will be updated.Since no specific root cause was identified and the risk is in the acceptable region, no correction action was deemed necessary.Livanova will keep monitoring the market.H3 other text : device not returned.

Event Description

See intial report.

• Brand Name: LILLIPUT HOLLOW FIBER OXYGENATOR D902
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola CO 41037
• 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: 13266472
• MDR Text Key: 287011518
• Report Number: 9680841-2022-00005
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)230225(10)2002260216(11)200226(240)05320
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K001021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: D902 PH.I.S.I.O.
• Device Catalogue Number: 05320
• Device Lot Number: 2002260216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1