MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PRIMO2X; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	PRIMO2X
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Abnormal Blood Gases (1034); Death (1802); Blood Loss (2597)
Date of Event	12/15/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 primo2x oxygenator.The incident occurred in (b)(6), usa.Per exemption number e2016005.The review of the dhr for the reported perfusion tubing set lot confirmed that the device was released in compliance with manufacturer specifications.The pump record and involved oxygenator were returned to livanova usa to be decontaminated before returning to sorin group (b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet received.
Event or Problem Description
Sorin group (b)(4) received a report that a low po2 value was recorded for a primo2x oxygenator during a circulatory-arrest case.The user reportedly checked the connections to make sure gas was flowing to the oxygenator.The fio2 was turned up as the patient was cooled to 18°c and the po2 declined.An o2 tank was connected as the patient was warmed, but they were unable to reach the expected po2 value.The oxygenator was changed out and the patient was taken off bypass.The patient experienced some bleeding issues and reportedly expired on (b)(6) 2017.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the primo2x oxygenator.The incident occurred in (b)(6).Per exemption number e2016005.The involved oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection of the device found no defect.A thorough investigation, including gas flow performance testing, of the returned device was unable to replicate the reported failure.The gas exchange performance (o2t and co2t) of the involved device was in line with product specifications.A review of the oxygenator dhr for the reported lot confirmed that the device was released in compliance with manufacturer specifications.As no pump-sheet of the case was provided for analysis and the issue could not be reproduced, a root cause could not be determined.

• Brand Name: PRIMO2X
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7177927
• Report Number: 9680841-2018-00003
• Device Sequence Number: 1090412
• Product Code: DTZ
• UDI-Device Identifier: 08033178100687
• UDI-Public: (01)08033178100687(17)200320(10)1703220041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: Other Health Care Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: PRIMO2X
• Device Catalogue Number: 050533
• Device Lot Number: 1703220041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 12/16/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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: Death