MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8 PH.I.S.I.O.
Medical Device Problem Codes	Low Readings (2460); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).(b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).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.
Event or Problem Description
Sorin group (b)(4) received a report that low oxygen levels were found by the perfusionist for the inspire 8 hollow fiber oxygenator then the blood gas parameter was analyzed upon the start of bypass.The perfusionist decided to switch to a new membrane oxygenator to continue.The change out was done after cooling down of the patient.Oxygen levels were restored after the change out.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir.The incident occurred in (b)(6).Per exemption number e2016005, (b)(4).The involved device was returned to sorin group italia for investigation.During visual inspection, no visible defects were noted.A gas exchange performance test was conducted per iso 7199 standard blood conditions.No device malfunction was identified during this testing.The involved device was found to be conforming to the manufacturer specifications.As the issue could not be reproduced, a root cause was not determined.However, the root cause is likely associated with the clinical practice.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 6787410
• Report Number: 9680841-2017-00022
• Device Sequence Number: 162860
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)200205(10)1702060154
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 02/05/2020
• Device Model Number: 8 PH.I.S.I.O.
• Device Catalogue Number: 050714
• Device Lot Number: 1702060154
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/14/2017
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1