MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL; HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

Catalog Number 050709

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 6 start oxygenator (catalog number 050709, lot 1604270096) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050709 is similar to the inspire 6 oxygenator 050713, which is distributed in the usa, for which the device identifier is (b)(4).The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The product item 050709 is not distributed in the usa, but it is similar to the inspire 6 oxygenator 050713, which is distributed in the usa (510(k) number: k130209).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 6 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.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.Device not yet returned.

Event Description

Sorin group (b)(4) has received a report that during a procedure, the po2 value droppet to 50 mmhg.During follow up information with the customer, on (b)(6) 2019, sorin group (b)(4) has been informed that the medical team elected to slow re-warming phase and to perform aerobic ventilation to solve the problem.According to information, the po2 of the patient was below of 50mmhg for nearly 50 minutes.There is no report of any patient injury.

Manufacturer Narrative

Sorin group italia manufactures the inspire 6 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in shenzhen, china.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and sorin group usa., inc.(importer).Nor the complained oxygenator neither pump sheet were provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on available information, no specific root cause could be assessed.Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
• Type of Device: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8432795
• MDR Text Key: 139221382
• Report Number: 9680841-2019-00012
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 050709
• Device Lot Number: 1604270096
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2019
• Device Age: 34 MO
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1