MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO; HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

Model Number	8F PH.I.S.I.O.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: patient information was not provided.Approximate age of device: the age of the device was calculated as the time elapsed between device sterilization and the date of the event.Sorin group (b)(4) manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).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
Livanova received a report that, during a cardiopulmonary bypass, leakage from the temperature probe holder was observed.The event occurred at the end of the procedure, when the perfusionist removed the temperature probe from the housing, it was not necessary to replace the oxygenating system.There was no leakage during surgery.The medical team elected to administer broad-spectrum antibiotic to the patient.There was no report of patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).The complained oxygenator was requested back for investigation several times and it was not returned to sorin mirandola.At the submission of the case, the customer has provided photographic evidences of the claimed problem in which it is visible blood leaking out from the internal side of the probe connector (no blood is expected to be found in the temperature probe housing).The issue experienced by the customer has been confirmed basing only on provided photographic evidences.Dhr verification did not reveal any relevant information possibly related to the claimed problem: the device has been released conforming to product specifications.Livanova has not been made aware of any other similar complaint relevant to the complained lot.Therefore, as systematic issue can be excluded.Based on similarity with previously investigated events, two root causes might trigger this type of leakages: delamination between the plastic/metal interface or integrity problem in the metal pin of the probe holder.Without the possibility to investigate the complained oxygenator, a specific root cause analysis cannot be performed.Despite the risk associated to this type of event is low and acceptable, as part of continuous improvement projects livanova is further investigating to identify possible corrective action(s) to further reduce occurrences.Livanova will keep monitoring the market.Device requested but not returned.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO
• Common Device Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8802337
• Report Number: 9680841-2019-00029
• Device Sequence Number: 18914011
• Product Code: DTZ
• UDI-Device Identifier: 08033178112383
• UDI-Public: (01)08033178112383(17)220415(10)1904160054
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 8F PH.I.S.I.O.
• Device Catalogue Number: 050716
• Device Lot Number: 1904160054
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention