MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES; OXYGENATOR, CARDIOPULMONARY BYPASS,

Catalog Number 03706

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The inspire 6 m oxygenator, lot number 1505180122, is a non-sterile device that was assembled into a convenience pack (catalog 044028600, lot 1522400081) and sterilized before distribution and use in the usa.Expiration date (mm/dd/yyy) of convenience pack: 08/31/3017.(b)(4).Device manufacture date (mm/dd/yyy) for convenience pack: 08/12/2015.The inspire 6 m hollow fiber oxygenator with integrated arterial filter hardshell venous/cardiotomy reservoir was assembled into a convenience pack for sterilization and distribution in the usa.The device is also distributed in the usa as a sterile device (510(k) number: k130433).Sorin group (b)(4) manufactures the inspire 6 hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that fluid was noted coming out of one of the water inlet/outlet ports of the inspire 6 m oxygenator during priming.There was no patient involvement.The device was returned to sorin group (b)(4) for evaluation.Leak testing of the returned unit confirmed the presence of a leak from the heat exchanger fiber bundle.Inspection of the bundle under magnification found that the leak was caused by damage to one of the fibers.Initially, this complaint was evaluated as not reportable.However, the damage to the heat exchanger identified during evaluation makes the event reportable.A retrospective review of complaints for this type of issue found that a medwatch report has not yet been submitted for this event.All units are 100% leak tested during the manufacturing process.Sorin group (b)(4) has concluded that the issue was likely related to an isolated defect in the fiber which was not apparent during in process testing.This defect has been classified as a rare event and no trend for this type of issue has been identified.Sorin group (b)(4) has initiated a capa for this type of issue and corrective actions were implemented in 2016 with the aim of improving the quality of the fibers and improving the effectiveness of in-process testing.The complained oxygenator was manufactured before the implementation of this corrective action.Sorin group (b)(4) has not received any reports of similar events involving units manufactured after the implementation of the corrective actions.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.

Event Description

Sorin group (b)(4) received a report that fluid was noted coming out of one of the water inlet/outlet ports of the inspire 6 m oxygenator during priming.There was no patient involvement.

• Brand Name: INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 6004154
• MDR Text Key: 56940293
• Report Number: 9680841-2016-00506
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03706
• Device Lot Number: 1505180122
• 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: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1