MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 8f hollow fiber oxygenator 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 convenience pack is (((b)(4)).The involved inspire 8f hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The stand-alone oxygenator (catalog number 050703) is also registered in the usa (510(k) number: k180448).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 hollow fiber oxygenator.The incident occurred in (b)(4); united states.The involved device has been requested for return to sorin group (b)(4) for investigation and it has not yet been received.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(6) has received a report that, during a procedure, red tinged water was noticed in the heater cooler lines of the inspire 8f oxygenator.The medical team elected to complete the procedure.There is not report of any patient injury.

Manufacturer Narrative

At the submission of the case, the devices (oxygenator and relevant circuit) were declared as available for investigation.However, despite several attempts, both devices were not made available for investigation and no picture of the issues was provided.Without possibility to investigate the oxygenator, no leak could be confirmed.The device failure claimed by customer cannot be confirmed.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant with the case.No other similar complaint has been received for the claimed product code /lot.As the defective device was not available for investigation the reported complaint cannot be confirmed.No root cause can be identified.No corrective action can be applied as no product failure could not be confirmed.Livanova will keep monitoring the market h3 other text : device not available.

Event Description

See initial report.

• Brand Name: INSPIRE 8F HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9568215
• MDR Text Key: 219775637
• Report Number: 9680841-2020-00002
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 03705
• Device Lot Number: 1909060035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1