MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00236

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient identifier, age and sex were not provided.The inspire 8m oxygenator was a non-sterile device assembled into a sterile convenience pack (item in00236).The catalog number, lot number, expiration date and udi number refer to the convenience pack.The complained inspire 8m oxygenator was a non-sterile device assembled into a convenience pack that is not distributed in the usa.The oxygenator is also distributed in the usa as a stand alone sterile device (510(k) number: k130433).Sorin group (b)(4) manufactures the inspire 8m oxygenator.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that, during cec, the fio2 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa.During re-warming, the surgeon elected to ventilate the patient and continue monitoring.There was no report of patient injury.The oxygenator will not be returned to sorin group (b)(4) for further analysis, as the device was inadvertently discarded by the customer.The investigation is on-going.A follow-up report will be sent when the investigation will be completed.Device discarded by user.

Event Description

Sorin group (b)(4) received a report that, during cec, the fio2 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa.During re-warming, the surgeon elected to ventilate the patient and continue monitoring.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 8m oxygenator.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, during cec, the fi02 levels increased from 75 to 100%, but the po2 would not rise above 19 kpa.During re-warming, the surgeon elected to ventilate the patient and continue monitoring.There was no report of patient injury.The complained device was discarded by the customer and was not available for return to sorin group (b)(4).The pump record was provided for analysis, which revealed that the po2 recorded values decreased 1 hour and 30 minutes after the start of the procedure.An inspire 8m oxygenator from a different lot was pulled from inventory and tested in similar conditions to those described in the pump record.Simulated use testing did not reproduce the reported issue and unit behaved as expected.The manufacturing record for the involved device was reviewed and the oxygenator was found to have met specifications upon release.As the complained device was not returned and the issue could not be reproduced on the sample oxygenator pulled from inventory, a root cause could not be determined and no corrective actions were identified.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Device discarded by customer.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via 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: 5828193
• MDR Text Key: 50617223
• Report Number: 9680841-2016-00494
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: IN00236
• Device Lot Number: 1601120062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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
• Patient Weight: 54