MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 DUAL HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES.; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	050714
Medical Device Problem Codes	Increase in Pressure (1491); Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(4) is submitting the report for (b)(4).A review of the dhr did not identify any deviation or non-conformity 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.Device not yet returned to manufacturer.
Event or Problem Description
Sorin group (b)(4) received a report that high transmembrane pressure was observed for the inspire 8 hollow fiber oxygenator at the beginning of a procedure.The medical team elected to continue the case.During the cooling phase, the oxygenator transmembrane pressure increased and the medical team elected replace the device at this time.The whole procedure was prolonged of 40 minutes.There is no report of any patient injury.
Additional Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator.The incident occurred in (b)(6).Per exemption number e2016005.(b)(4).The oxygenator was returned to sorin group (b)(4) for investigation.The device was gamma sterilized followed by a visual inspection, which identified traces of blood residuals and deposits near the blood outlet.The device was subjected to pressure drop testing at different blood flow-rates using bovine blood.The results of the testing identified pressure drop values above the expected range, indicative of possible fibrin deposits in the fibers.An autopsy of the device revealed a uniform biological residue trapped by the net of the oxygenator and the heat exchanger fiber bundles, and a few biological traces were found on the heat exchanger core.Based on the evidence of device autopsy, sorin group (b)(4) has confirmed that the increased pressure drop was caused by platelet adhesion and fibrin layer deposits inside the oxygenator.The most probable root cause of platelet adhesion and fibrin layer deposition is not device specific but rather multi-factorial including clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.

• Brand Name: INSPIRE 8 DUAL HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES.
• 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: 6338721
• Report Number: 9680841-2017-00003
• Device Sequence Number: 16349383
• Product Code: DTZ
• UDI-Device Identifier: 08033178112369
• UDI-Public: (01)08033178112369(17)191215(10)1612150002
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 12/15/2019
• Device Catalogue Number: 050714
• Device Lot Number: 1612150002
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/24/2017
• Device Age: 1 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1