MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided.The inspire 8f m 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 pending.The involved inspire 8f m oxygenator is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone 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 m oxygenator.The involved device has been requested for return to sorin group (b)(4) for investigation and not yet 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.

Event Description

Sorin group (b)(4) has received a report that, at the begin of a procedure, the patient blood oxygenation was low.Medical team elected to change-out the oxygenator.The procedure was completed with no issue.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

Livanova received report that, during procedure using inspire 8f with fio2=100%, arterial blood was noted to be dark and lab results confirmed low po2 values.To solve the problem, oxygenator change out was performed; no patient outcome was reported.Based on the available pump sheet, by keeping the fio2 at 100%, hemoglobin oxygen saturation (so2) was around 80% and the po2 value lowered from 191 mmhg (pre cpb) to 48 mmhg, confirming the event.According to what recommended by ifu, medical team tackled and solved the issue by replacing the device: perfusion was interrupted for approximately one minute.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.The noticed lot was not involved in other similar complaints.Many different failure mechanisms can be assumed to cause the complained defect.A possible hypothesis is that the issue is multi-factorial, where a combination of triggering factors might be originating the phenomenon, including interaction with clinical procedure and patient conditions.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.

Event Description

See initial report.

Manufacturer Narrative

The involved inspire oxygenator 8f has been returned to livanova facility for investigation.Device was decontaminated as per livanova procedure on blood contaminated goods.No visible traces of blood inside fiber bundle have been observed; some residues were present in the filter.Based on investigation data, the claimed device was found to be properly working with no deviation identified relating to blood oxygenation capability.In details, po2 values were found to be within specifications.In addition, as shown in the picture of the investigation, water condensation phenomenon inside microporous fibers was also observed; it is reasonable to correlate this unexpected behavior of the oxygenator with fibers hydrophilization most likely associated with high-humidity storage conditions.Based on all gathered facts, no direct relationship between complained event and any possible device-related quality problem was confirmed.Livanova will keep monitoring the market for similar events.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 10942359
• MDR Text Key: 234434809
• Report Number: 9680841-2020-00017
• 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,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 03705
• Device Lot Number: 2007270093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1