MAUDE Adverse Event Report: SORIN GROUP ITALIA HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Unit not yet returned to sorin group (b)(4) for investigation.Sorin group (b)(4) manufactures the inspire 6f dual oxygenator.The incident has occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that during set-up, the arterial outlet port of the inspire 6f was found to be broken.The unit was not used.There no patient involvement.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that during set-up, the arterial outlet port of the inspire 6f was found to be broken.The unit was not used.There was no patient involvement.

Manufacturer Narrative

(b)(4).Sorin group received a report that during set-up, the arterial outlet port of the inspire 6f was found to be broken.The unit was not used.There's no patient involvement.Follow-up communication with the customer has revealed that the inspire oxygenator has been discarded and is no longer available to send to sorin group (b)(4) for investigation.Without the ability to evaluate the involved unit or a customer photograph, a root cause for this issue could not be determined.No trend has been identified for this type of issue.This is the first report for this type of failure since the release of this product onto the market in september 2013.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.Device discarded by user.

• Brand Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo), italy 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo), italy 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5167399
• MDR Text Key: 28909151
• Report Number: 9680841-2015-00488
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 050719
• Device Lot Number: 1410270068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1