MAUDE Adverse Event Report: SORIN GROUP ITALIA HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Lot number was not provided by the customer.The expiration date could not be determined.Pma 50(k): the inspire 8f m hollow fiber oxygenator was assembled into a customized circuit code (b)(4) that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510k#: k130433).Mfg date: lot number was not provided, so the manufacture date is unknown.Sorin group (b)(4) manufactures the customized pack containing the inspire 8m 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 received a report that the inspire 8f m hollow fiber oxygenator, assembled into a customized circuit, leaked from the gas relief port during the procedure.The device was not changed and the procedure was completed with no other issue.There was no report of patient injury.This 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 8f m hollow fiber oxygenator, assembled into a customized circuit, leaked from the gas relief port during the procedure.The device was not changed and the procedure was completed with no other issue.There was no report of patient injury.

Manufacturer Narrative

Traceability was completed and the expiry date of the finished sterile customized pack is: 08/31/2018.Traceability was completed and the manufacturing date of the finished sterile customized pack is: 11/01/2015.Sorin group (b)(4) manufactures the customized pack containing the inspire 8m 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 8f m hollow fiber oxygenator, assembled into a customized circuit, leaked from the gas relief port during the procedure.The device was not changed and the procedure was completed with no other issue.There was no report of patient injury.This event was reported to the country's local competent authority.This medwatch report is being filed in response to this action.The involved device was returned to sorin group (b)(4) for further investigation.Visual inspection of the returned oxygenator found no defects, however dried blood was noted on the ends of the fiber bundle, suggesting a leak had occurred during usage.A leak tests was performed on the device, however the reported issue could not be reproduced.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The oxygenator passed the in-process controls, including a leak test, and was released in compliance with product specifications.As the issue could not be reproduced, a root cause could not be determined and no corrective actions were identified, however sorin group (b)(4) plans to introduce an automated vision system to enhance the in-process control of inspire oxygenator fiber integrity and eliminate any possibility of human error during visual in-process control.

• Brand Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola, modena 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: 5386602
• MDR Text Key: 36707658
• Report Number: 9680841-2015-00678
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Risk Manager
• Device Model Number: N/A
• Device Catalogue Number: IN00340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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