MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6 HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	6F PH.I.S.I.O.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.Patient ethnicity was not provided.(b)(6).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.Per exemption number e2016005.The involved device is reportedly not available for investigation.However, a video was provided.Inspection of the video confirmed that a leak occurred from the bottom of the oxygenator.It was not possible to asses the leaking point with certainty.No definitive conclusion can be drawn on the cause of the event without the device for investigation.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturing specifications.Frequency of this type of event is low.Sorin (b)(4) will continue to monitor the market for similar events.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available for return.
Event or Problem Description
Sorin (b)(4) received a report of a blood leak from the lower portion of an inspire 6f hollow fiber oxygenator during a procedure.According to the customer, the total blood loss was of 1000 ml and the patient was hemo-transfused.There was no report of patient injury.

• Brand Name: INSPIRE 6 HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
• 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: 7746125
• Report Number: 9680841-2018-00025
• Device Sequence Number: 13724245
• Product Code: DTZ
• UDI-Device Identifier: 08033178112376
• UDI-Public: (01)08033178112376(17)190926(10)1609260148
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K130209
• 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
• Report Date (Section B): 08/03/2018

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: 09/26/2019
• Device Model Number: 6F PH.I.S.I.O.
• Device Catalogue Number: 050715
• Device Lot Number: 1609260148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2018
• Device Age: 21 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 64