MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03704

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The inspire 6f m dual hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack into which the oxygenator was assembled is (b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).The involved inspire 6f m hollow fiber oxygenator with integrated arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050702) is also registered in the usa (510(k) number: k130209).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.(b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation but not yet returned.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that the blood flow through the inspire 6f m dual hollow fiber oxygenator dropped from 4.5 lpm to 2.5 lpm three minutes after initiation of cardiopulmonary bypass.There were no modifications made to the pump speed which would have caused this change.The medical team elected to change-out the oxygenator.The patient was ventilated.There was no report of patient injury.

Manufacturer Narrative

Sorin group italia manufactures the inspire 6f m dual hollow fiber oxygenator.The incident occurred in new york, new york.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) the involved device was returned to sorin group italia for evaluation.Visual inspection identified no defects or non-conformities.Biological traces, blood clots and biological deposits, were found in the integrated arterial filter.The device was extensively rinsed, however it was not possible to remove all biological traces.Therefore, it was not possible to submit the device to transmembrane pressure verification as the flowing of water through the device was impaired by the biological deposits.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on the evidence of device inspection and on previously investigated similar cases, sorin group italia believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of 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 event does not appear to be device specific.

• Brand Name: INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 7972999
• MDR Text Key: 123959502
• Report Number: 9680841-2018-00027
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 03704
• Device Lot Number: 1805030092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1