MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	8 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	01/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Sorin group (b)(4) manufactures the inspire 8 oxygenator.The incident occurred in (b)(6).(b)(4).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.A follow-up report will be sent once the investigation is complete.
Event or Problem Description
Sorin group (b)(4) received a report that traces of blood were observed in the water outlet of the inspire 8 dual hollow fiber oxygenator about 50 minutes after starting bypass.The medical team opted to continue the surgery without changing the oxygenator.The procedure was completed without issue.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8 oxygenator.The incident occurred in (b)(6).Per exemption number e2016005.(b)(4).The defective device was returned to sorin group (b)(4) for investigation.The device was subjected to pressure testing in order to confirm the blood to water leak.Under slight over-pressurization, drops of fluid were identified exiting from the blood side of the heat exchanger.A tac scan revealed a small detachment between the heat exchanger fiber bundle and the inner core, which caused the leak.The root cause of the detachment remains unknown.The present complaint was an isolated event.No other similar defects have been recorded in the last year over more than (b)(4) units sold worldwide.
Additional Manufacturer Narrative
(b)(4).Per exemption number e2016005.Further autopsy of the heat exchanger core revealed a thin plastic residue trapped in the potting resin where the leak occurred.Spectroscopic analysis of the debris determined it was a portion of the bag used for handling the sub-assembly.According to internal records, the identified defect is a rare event with very low occurrence (less than 1 10-5).No similar events with the same root cause have been reported in the last 24 months.

• Brand Name: INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTO
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena)
• MDR Report Key: 6289851
• Report Number: 9680841-2017-00002
• Device Sequence Number: 885893
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)181123(10)1511230036
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup,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: 11/23/2018
• Device Model Number: 8 PH.I.S.I.O.
• Device Catalogue Number: 050714
• Device Lot Number: 1511230036
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/02/2017
• Device Age: 14 MO
• Initial Date Received by Manufacturer: 01/02/2017
• Supplement Date Received by Manufacturer: Not provided; 09/29/2017
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 05/19/2017; 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1