MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D101 DIDECO KIDS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D101 PHISIO
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the d101 dideco kids.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation.According to follow up information with the customer, based on pump data sheet, it was possible to highlight that the values of po2 = 43 mmhg and o2sat = 71%.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.
Event or Problem Description
Sorin group (b)(4) has received a report that, during the administration of the cardioplegia during a procedure, a leak from the kids d101 oxygenator was observed.The medical team elected to change out the oxygenator.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report of blood leakage in proximity to gas port of a d101 kids oxygenator.The issue was identified during procedure.Medical team elected change-out the oxygenator and no information on duration of change-out was provided.At the submission of the case, the customer provided an explicative picture of the failure showing blood leak from gas port of the oxygenator.Oxygenator was returned to livanova.Visual inspection of the device did not identify any obvious damage.To verify the integrity of the device, a leak test on blood side was performed.No leak could be reproduced.Dhr verification of the complained lot confirmed the devices was released conforming to specifications.Review of the livanova complaints database confirmed no other similar event was recorded relevant to the complained lot thus excluding a systematic issue.Livanova believes the most probable root cause of the leakage was related to damages in the oxygenator fiber bundle(s) that allowed the blood to enter the cavity of the fiber and, due to the gas flow direction, to exit in proximity to gas escape port.According to manufacturing procedures, 100% of the units are leak tested before release.The claimed unit has passed the test.Therefore, it cannot be ruled out that the damaged fibers are due to intrinsic fragility of the fibers enhanced by thermal and mechanical stresses following device release.A possible explanation on the reason why the leak was not reproduced is that the dried blood might have has plugged the cavity of the damaged fiber(s) thus sealing the fiber and making it impossible to reproduce the defect.During investigation analysis it was clarified the initial reported po2 value was related to venous blood gas analysis and therefore the reported value (43mmhg) is an acceptable value.Since the residual risk is in the acceptable region, no corrective action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: D101 DIDECO KIDS
• 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: 13119535
• Report Number: 9680841-2021-00041
• Device Sequence Number: 17272590
• Product Code: DTZ
• UDI-Device Identifier: 08033178109291
• UDI-Public: (01)08033178109291(17)241012(10)2110140022(11)211014(240)050540
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K072091
• 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): 03/25/2022

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: 10/12/2024
• Device Model Number: D101 PHISIO
• Device Catalogue Number: 050540
• Device Lot Number: 2110140022
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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