MAUDE Adverse Event Report: SORIN GROUP ITALIA D100 NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS,

Catalog Number	050531
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that, after 10 minuntes from initiation of cardiopulmonay bypass, the kids d100 neonatal oxygenator was leaking.Medical team elected to change out the oxygenator.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures thekids d100 neonatal oxygenator.The incident occurred in india.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
No further information could be retrieved from customer, regarding change out duration, phase of the procedure during which item was replaced (before/during cross clamp), precise leakage area indication (junction point between blood outlet port and threaded luer port where temperature probe is screwed / gas outlet port).Moreover, no pictures were shared and no confirmation of item availability was provided.Verification of manufacturing records pointed out that noticed device was released as conform according to specifications.Analysis of complaints database revealed one other event associated to the same oxygenator lot.That event was of leak from the gas outlet port of the oxygenator.This type of leak is cause by damaged capillary in the fiber bundle of the oxygenator module.During manufacturing, 100% of the oxygenators are subjected to final leak test and the involved oxygenator successfully passed the in-process check.No trend has been registered for similar case.Bases on all the above, it cannot be excluded that the complained leak was a damaged fiber and fiber bundle capillary manufacturing variability with contribution of thermal and/or transportation mechanical stress could have led to breakage during use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: D100 NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS,
• Manufacturer (Section D): SORIN GROUP ITALIA; 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: 18254551
• Report Number: 9680841-2023-00043
• Device Sequence Number: 15230822
• Product Code: DTZ
• UDI-Device Identifier: 08033178100359
• UDI-Public: (01)08033178100359(17)250901(10)2209020061(240)050531
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 09/01/2025
• Device Catalogue Number: 050531
• Device Lot Number: 2209020061
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2022
• 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