MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN./CARDIO. RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050714

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.Unique identifier (udi) number: (b)(4).Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).On november 7, 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority.The complained oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection of the returned oxygenator confirmed the disconnection of the cardioplegic connector from the oxygenator.The disconnection was caused by excessive solvent applied by the manufacturing operator, which impaired the proper adhesion of the two components of the connector.Sorin group (b)(4) has not been informed of any other similar events related to this lot.A review of the dhr did not reveal any relevant information related to the reported issue.As the root cause was identified to be an assembly error, the manufacturing floor was formally informed and trained to sensitize the personal to this issue.The occurrence rate for this type of issue is very low.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

Event Description

Sorin group (b)(4) has received a report that the cardioplegic connector detached from the inspire 8 dual hollow fiber oxygenator housing when the user tried to connect the cardioplegic line to the relevant fitting.The device was exchanged for the procedure.The event occurred during setup.There was no patient involvement.

• Brand Name: INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN./CARDIO. RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 6144614
• MDR Text Key: 61446034
• Report Number: 9680841-2016-00517
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130433
• 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
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2019
• Device Catalogue Number: 050714
• Device Lot Number: 1605100010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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