MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ART. FILTER AND HARDSHELL VEN/CARD RES; HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN/CARD RESERVOIR

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.Per exemption number e2016005.Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).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 the pre-membrane pressure of an inspire 8f hollow fiber oxygenator and the tension of the tubing between the pump outlet and the oxygenator inlet increased during a procedure.The report also indicated that the pump flow could not be set higher than 2 lpm.The medical team elected to change out the oxygenator, which took roughly 200 seconds.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 8f hollow fiber oxygenator.The incident occurred in karachi, pakistan.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).In the initial report, it was incorrectly stated that the involved device had been requested for return to sorin group italia for investigation.The event occurred on (b)(6) 2018.The customer notified sorin group italia only two months later.Based on previously investigate similar cases, sorin group italia had determined that after a certain length of time has elapsed between the event date and the investigation date, the physical investigation of the device is not capable of yielding meaningful results.Therefore, the unit has not been requested for return.The pump sheet for the event has not been provided.A review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.Based on evidence from previously investigated cases, sorin group italia believes the most likely root cause of the reported increased pressure issue to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable cause for the platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.Too much time elapsed from event date.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ART. FILTER AND HARDSHELL VEN/CARD RES
• Common Device Name: HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN/CARD RESERVOIR
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7454954
• Report Number: 9680841-2018-00009
• Device Sequence Number: 13727446
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)200606(10)1706080232
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 06/06/2020
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1706080232
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/12/2018
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 60