MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR; INSPIRE 7 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL/VENOUS CARDIOTOMY RE

Model Number	7
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were 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.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) has received a report that during a procedure, transmembrane pressure rose.Gas exchange performances were not affected.The medical team elected to administer nitroprusside and ringer acetate to the patient.The procedure was completed with no issue: the transmembrane pressure was stabilized and it decreased to standard values.There was no report of any patient injury.
Additional Manufacturer Narrative
Sorin group italia manufactures the inspire 7 hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in umea, sweden.The involved device has been returned to the manufacturer.Visual inspection results in no structural defect neither any residual blood traces found.To investigate the presence of possible biological traces, related to the claimed failure, the device was rinsed with formaldehyde solution and sectioned.No biological deposits were identified neither within the oxygenator fiber bundle nor in the heat exchanger fiber bundle.As per the evidences collected, the root cause of the event could not be traced to any device-related malfunction since the increase of hydraulic resistance experienced by customer is related to undesired cellular activation associated with platelet adhesion and fibrin layer deposition inside the oxygenator.Based on medical literature, the origin of the activation and interaction appear to be not device related and to be multi-factorial in nature.For this reason, no specific corrective action has been identified at the present date.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
• Common Device Name: INSPIRE 7 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL/VENOUS CARDIOTOMY RE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8543114
• Report Number: 9680841-2019-00018
• Device Sequence Number: 2431336
• Product Code: DTZ
• UDI-Device Identifier: 08033178113212
• UDI-Public: (01)08033178113212(17)220110(10)1901110208
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190690
• 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): 07/25/2019

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: 01/10/2022
• Device Model Number: 7
• Device Catalogue Number: 050727
• Device Lot Number: 1901110208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1