MAUDE Adverse Event Report: SORIN GROUP ITALIA LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D902
Medical Device Problem Codes	Leak/Splash (1354); Low Readings (2460); Device Operational Issue (2914)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.Per exemption number e2016005.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report; device not yet returned.
Event or Problem Description
Sorin group italia received a report that the po2 values dropped to 43.6 mmhg and blood droplets were noticed coming out from the lilliput 2 infant hollow fiber oxygenator gas vent port 10 minutes into a procedure.The medical team elected to change out the oxygenator and the procedure was completed with no further issues.During follow-up communication with the customer, the patient developed sepsis and the icu stay was prolonged 14 days.
Additional Manufacturer Narrative
Sorin group italia manufactures the lilliput 2 infant hollow fiber oxygenator.The incident occurred in belgaum, karnataka, india.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved oxygenator was returned to sorin group italia for investigation free of any blood contamination/residuals.Attempts were made to identify which chemical or procedures were utilized to clean the oxygenator.However, these attempts were unsuccessful.The oxygenator was subjected to functional testing with bovine blood.The results of the gas transfer performance were found to be in line with the product specifications.The oxygenator performed as expected.A dhr verification did not reveal any relevant information possibly linked with the reported defect.The reported lot has not been involved in any other complaint.As the issue could not be reproduced, the root could not be determined, and corrective actions were not identified.

• Brand Name: LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7649500
• Report Number: 9680841-2018-00016
• Device Sequence Number: 16583057
• Product Code: DTZ
• UDI-Device Identifier: 08033178100304
• UDI-Public: (01)08033178100304(17)200919(10)1709210228
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K971877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: D902
• Device Catalogue Number: 05324
• Device Lot Number: 1709210228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2018
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 4 YR
• Patient Weight: 13