MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTO; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050717

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the inspire 6 dual 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 the inspire 6 dual hollow fiber oxygenator experienced a leak from the connector of the temperature probe during priming.The device was replaced.The issue occurred during priming so there was no patient involvement.The event was reported to the country's local competent authority.This medwatch report is being filed in response to this action.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 the inspire 6 dual hollow fiber oxygenator experienced a leak from the connector of the temperature probe during priming.The device was replaced.The issue occurred during priming so there was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 6 dual hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The event occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the inspire 6 dual hollow fiber oxygenator experienced a leak from the connector of the temperature probe during priming.The device was replaced.The issue occurred during priming so there was no patient involvement.The event was reported to the country's local competent authority.This medwatch report is being filed in response to this action.The involved oxygenator was returned to sorin group (b)(4) for evaluation.Visual inspection of the returned device did not identify any issues.Magnifying instruments were used to examine the device near the temperature probe and no cracks or damage to the integrity of the returned device was discovered.The device was subjected to simulated use testing for 6 hours (the recommended use duration) at elevated pressures and no leak could be reproduced.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.As the internal investigation was unable to reproduce the reported failure, a root cause could not be determined and no corrective actions were identified.

• Brand Name: INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (modena), italy 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5272531
• MDR Text Key: 32871060
• Report Number: 9680841-2015-00585
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121909
• 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: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2018
• Device Catalogue Number: 050717
• Device Lot Number: 1507220111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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