MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03705

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 8f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (lot 1707250129) 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 complained 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).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 obtained, it will be provided in a supplemental report.Device not returned.

Event Description

Sorin group (b)(4) received a report that the trans-membrane pressure of the inspire 8f m oxygenator began to increase after 20 minutes of bypass and continued to rise.The perfusionist decreased the flow rate and eventually had to stop circulation due to the high pressure.Following the procedure, the perfusionist was unable to drain the circuit by aspirating the oxygenator outlet.The user was able to drain the circuit after aspirating the inlet.The user believes that debris or clots may have clogged the oxygenator and created high inflow resistance.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in (b)(6).Per exemption number e2016005, (b)(4).The involved device was returned to sorin group (b)(4) for investigation.The device was submitted to testing for verification of the transmembrane pressure drop, which found that the measured pressure drop values were within the device specification.The device was found to be performing as expected.As the issue was not reproduced, a root cause was not determined.However, based on the evidence from previously investigated cases, sorin group (b)(4) believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.

Manufacturer Narrative

Sorin group italia manufactures the inspire 8f m hollow fiber oxygenator.The incident occurred in (b)(6), canada.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and (b)(4).(importer).During follow-up communication with the customer, sorin group italia was provided the pump sheet for the event.Analysis of the data confirmed that the customer experienced an increased transmembrane pressure event during the procedure.Based on the evidence from previously investigated cases, sorin group italia believes a likely root cause of the increased pressure drop to be platelet adhesion and fibrin layer deposition inside the oxygenator.The most probable root cause of platelet adhesion and fibrin deposition is multi-factorial and includes the clinical procedure (e.G surgical material), therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.The failure appears to not be device-specific.

• Brand Name: INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7142804
• MDR Text Key: 95935291
• Report Number: 9680841-2017-00036
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 07/23/2020
• Device Catalogue Number: 03705
• Device Lot Number: 1708020205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Distributor Facility Aware Date: 12/04/2017
• Device Age: 4 MO
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1