MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03704

Device Problems Low Readings (2460); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

The complained inspire 6f hollow fiber oxygenator with integrated arterial filter is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile sterile convenience pack is: (b)(4).The age of the device was calculated as the time elapsed from device sterilization and the date of event.(b)(4).The complained inspire 6f hollow fiber oxygenator with integrated arterial filter is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand alone oxygenator (catalog number 050702) is registered in the usa (510(k) number: k130209).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 6f hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6).Per exemption number (b)(4), sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4).(importer).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that the arterial gas (oxygen) levels were low during a procedure.The inspire 6f oxygenator was changed out to resolve the issue.On (b)(6) 2017, sorin group (b)(4) received a user medwatch report (mw5067887) regarding this event.The report stated that the patient's vital signs and levels remained constant throughout the procedure and that no residual effects or complications were noted post procedure.

Manufacturer Narrative

(b)(4).The involved oxygenator was returned to sorin group (b)(4) for investigation.Simulated use testing was performed in standard conditions while monitoring gas exchange performances.The testing showed that the oxygenator performed according to product specifications and no failure could be reproduced.The manufacturing record for the involved device was reviewed and the oxygenator was found to have met the manufacturer's specifications upon release.The reported lot has not been involved in other similar complaints.As the issue could not be reproduced, the root cause was not identified and corrective actions were not determined.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo)
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6394281
• MDR Text Key: 69575577
• Report Number: 9680841-2017-00005
• 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,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 03704
• Device Lot Number: 1609070141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/10/2017
• Device Age: 4 MO
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• 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