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

Catalog Number IN00396

Device Problem Increase in Pressure (1491)

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

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

No patient information were provided.The unit has not yet been returned to sorin group (b)(4).The inspire 6f m was assembled into a customized circuit (item (b)(4)) that is not distributed in the usa, but the oxygenator is similar to the inspire 6f m that is distributed in the usa (510k#: k120185).Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood.The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful.The procedure was stopped in order to replace the oxygenator.The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali).The patient is awake but has not been discharged from the hospital.The oxygenator and tubing are delivered to the customer as separate parts, and the connection between the oxygenator inlet and the corresponding tubing is made by clinical personal.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.A follow-up report will be sent when the investigation will be completed.

Event Description

Sorin group (b)(4) received a report that two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood.The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful.The procedure was stopped in order to replace the oxygenator.The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali).The patient is awake but has not been discharged from the hospital.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that two minutes after the start of the cec procedure, there was a sudden increase of the premembrane pressure of the inspire 6f m oxygenator, followed be a significant blood leak from the oxygenator inlet, resulting in the loss of about 4l of blood.The user attempted to reconnect the tube onto the oxygenator inlet connector, but was unsuccessful.The procedure was stopped in order to replace the oxygenator.The patient was infused with 8 blood bags which led to transfusion-related acute lung injury (trali).The current patient status is unknown.The oxygenator and tubing are delivered to the customer as separate parts, and the connection between the oxygenator inlet and the corresponding tubing is made by clinical personal.Despite several attempts made by sorin group (b)(4) to retrieve information regarding the patient status and to have the involved unit returned for investigation, the hospital has not disclosed any new information, nor provided the device for investigation.Without the ability to investigate the unit, sorin group (b)(4) cannot determine a root cause or identify corrective actions.Such a connection was performed by the clinical personal and it cannot be excluded that the tubing was incorrectly fit onto the blood-inlet connector.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 (modena), 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5707764
• MDR Text Key: 46853837
• Report Number: 9680841-2016-00376
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: IN00396
• Device Lot Number: 1510230018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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