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

Model Number	05320
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the lilliput oxygenator.The incident occurred in india.Through follow-up communication, livanova learned that the change-out of the oxygenator was performed after few minutes of bypass initiation with the aortic cross clamped and lasted more than 3 minutes.The poor oxygenation performance was detected early in the surgery (around 10 minutes since beginning of bypass).The unit was replaced with another unit of different lot number, and no tracking of the delta pressure across the device was measured at the time of failure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia has received a report that, during a pediatric cardiac surgery, after few minutes of cardiac bypass initiation, it was found that the p02 levels blood gas were 90mmhg with fi02 100%.Medical team repeat sample and showed 99mmhg.Medical team evaluated the value not acceptable and elected to change out the oxygenator.There is no report of any patient injury.
Additional Manufacturer Narrative
According to the review of previous similar events, factors potentially contributing to the occurred issue are the following: - shunt effect derived from a reduced interference between oxygenator body and winding fiber system leading to the onset of a preferential pathway of the blood across the oxygenator (isolated manufacturing deviation) - decreased number of capillaries inside fibre bundle due to low fiber density (isolated supplier deviation) - decreased porosity of fibre bundle, due to isolated supplier deviation or accidental occlusion of pores during livanova manufacturing process - non-conforming thickness of fibers wall, leading to increase of gas pathway length to perform gas exchange (isolated manufacturing deviation) - improper settings by user (blood-gas parameters) or specific characteristics of patient blood (high hematocrit) - deposition of biological substances between fibers, leading to reduction of effective area to perform gas exchange and concomitant increase of gas pathway length to perform gas exchange (adverse event procedure-related).Based on the available information, taking into account that noticed lot of oxygenator was not complained by other customers and considering that no concerning adverse trend was identified for poor performance issue of lilliput non-ecmo devices from post market data surveillance, no systematic quality deviation in the manufacturing process was established.Therefore, it cannot be ruled out that the most likely root cause of the reported event was multifactorial, resulting from the interaction between clinical procedure, patient conditions and gas-blood settings.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.Livanova will keep monitoring the market.

• Brand Name: D902 DIDECO LILLIPUT PHISIO
• 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; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 19228063
• Report Number: 9680841-2024-00014
• Device Sequence Number: 6882504
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)260729(10)2307300015(11)230730(240)05320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971877
• 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): 07/18/2024

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: 07/29/2026
• Device Model Number: 05320
• Device Lot Number: 2307300015
• Was Device Available for Evaluation?: Yes
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown