MAUDE Adverse Event Report: SORIN GROUP ITALIA D903 AVANT 2 OXYGENATOR PHISIO COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	D903 DIDECO AVANT 2 PHISIO
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Initial reporter contact phone number is: (b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the d903 avant 2 physio coated oxygenator.The incident occurred in (b)(6).Per exemption number e2016005.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 (b)(4) received a report that transmembrane pressure of the d903 avant 2 oxygenator increased during a procedure.During follow-up communication with the customer on (b)(6) 2018, sorin group (b)(4) was informed that nitroprusside was administered to the patient.There was no report of any patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the d903 avant 2 phisio coated oxygenator.The incident occurred in edmonton, canada.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 device was returned to sorin group italia for investigation.During visual inspection, no visible defects were noted.The device was tested in order to evaluate the pressure drop in standard conditions.No device malfunction was identified during this testing.The device was found to be conforming to manufacturer specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not determined.However, one possible root cause is transient undesired cellular activation.This root cause is multi-factorial in nature and not device specific.

• Brand Name: D903 AVANT 2 OXYGENATOR PHISIO COATED
• 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: 7684668
• Report Number: 9680841-2018-00019
• Device Sequence Number: 1315663
• Product Code: DTZ
• UDI-Device Identifier: 08033178100106
• UDI-Public: (01)08033178100106(17)200506(10)1705080145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033323
• 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): 09/27/2018

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: 05/06/2020
• Device Model Number: D903 DIDECO AVANT 2 PHISIO
• Device Catalogue Number: 05338
• Device Lot Number: 1705080145
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2018
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1