MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL RES.; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problems Use of Device Problem (1670); Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

The inspire 8f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (lot 1805030121) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The age of the device was calculated as the time elapsed between device sterilization and the date of event.(b)(4).The inspire 8f m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone oxygenator (catalog number 050703) is registered in the usa (510(k) number: k130433).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 8f m hollow fiber oxygenator.The incident occurred in (b)(6).(b)(4).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 obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received a report that the color of the blood passing through the inspire 8f hollow fiber oxygenator appeared dark during a procedure.Blood analysis reportedly identified a blood saturation of 86% and an o2 pressure of 47mmhg.The perfusionist increased the fio2 and repeated the blood analysis, however the values did not improve significantly.The procedure was completed.There is no report of patient injury.

Manufacturer Narrative

Sorin group italia manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in torrette di ancona, italy.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved inspire 8f oxygenator was returned to sorin group italia for investigation.The oxygenator was subjected to functional testing with bovine blood and the results of the gas transfer performance were found to be in line with product specifications.The oxygenator performed as expected.A review of the dhr did not reveal any relevant information possibly linked with the claimed defect.The complained lot has not been reported in any other complaint.As no pump-sheet of the case was provided for analysis and the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL RES.
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; via statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7856183
• MDR Text Key: 119654937
• Report Number: 9680841-2018-00026
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 03705
• Device Lot Number: 1805110052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2018
• Device Age: 3 MO
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1