MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00159

Device Problem Fluid/Blood Leak (1250)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

The inspire 6f m hollow fiber oxygenator was assembled into a customized circuit, code (b)(4), that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510(k) number: k130209).Sorin group (b)(4) manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that a blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure.The origin of the leak could not be identified.The oxygenator and circuit were changed out to complete the procedure.The blood loss was estimated to be between 500ml and 1000ml.On may 3, 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that a blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure.The origin of the leak could not be identified.The oxygenator and circuit were changed out to complete the procedure.The blood loss was estimated to be between 500ml and 1000ml.On may 3, 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Soring group (b)(4) received a report that a blood leak was seen at the bottom of the inspire 6f hollow fiber oxygenator with integrated arterial filter and hardshell 20 to 30 minutes into the ecc procedure.The origin of the leak could not be identified.The oxygenator and circuit were changed out to complete the procedure.The blood loss was estimated to be beween 500ml and 1000ml.On (b)(6) 2016, sorin group was informed that the patient was in intensive care under left ventricular assist device support and temporary right ventricle circulatory support.The involved oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection of the returned device identified a crack in the male luer.A leak test was performed at the maximum recommended pressure level, however the leak could not be reproduced.The purge line was stretched and the test was repeated, at which point a leak was observed between the male connector of the purge line and the female connector of the oxygenator, originating from the male luer.A simulation of excessive torque was performed, however the defect was not reproduced.Through further investigation, sorin group (b)(4) determined that the leak described by the customer was caused by a deformation inside the male connector, likely generated during molding.The occurrence rate for this type of issue is very low, however the supplier of the connector has been notified of the event.A review of the dhr was unable to identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5668497
• MDR Text Key: 45569354
• Report Number: 9680841-2016-00305
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: IN00159
• Device Lot Number: 1602010136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other