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

Catalog Number 050717

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

The unit has not been yet returned to the manufacturer facilities for investigation.Sorin group italia manufactures the inspire 6 dual hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group italia.Sorin group italia received a report that the inspire 6 dual hollow fiber oxygenator would not oxygenate for half of the procedure.The oxygenator was used to complete the procedure.There was no report of patient injury.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group italia received a report that the inspire 6 dual hollow fiber oxygenator would not oxygenate for half of the procedure.The oxygenator was used to complete the procedure.There was no report of patient injury.

Manufacturer Narrative

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 report 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 would not oxygenate for half of the procedure.The oxygenator was used to complete the procedure.There was no report of patient injury.This event was reported to the country's local competent authority.This medwatch report was filed in response to this action.The involved oxygenator was returned to sorin group (b)(4) for evaluation.A visual inspection found no defects or abnormalities.Functional testing of the oxygenator was unable to reproduce the reported issue.No evidence of a device malfunction was identified, and all performance values were found to be in line with the manufacturer's specifications.As the reported issue could not be reproduced, a root cause could not be identified and corrective actions were not determined.However sorin group (b)(4) has initiated a capa investigation in relation to other complaints for similar issues.

• Brand Name: INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY
• 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; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5231699
• MDR Text Key: 31450978
• Report Number: 9680841-2015-00537
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2018
• Device Catalogue Number: 050717
• Device Lot Number: 1506290102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• 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