MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Increase in Pressure (1491)

Patient Problem Loss of Vision (2139)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

Pma 510(k): the inspire 8f m hollow fiber oxygenator was assembled into a customized circuit, code in00092, that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510(k) number: k130433).Sorin group (b)(4) manufactures the inspire 8m hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, during bypass, a high premembrane pressure was detected for the inspire 8m oxygenator.The perfusionist elected to continue using the device and to complete the procedure.Following the procedure, the patient experienced blindness.It was reported on (b)(6) 2016 that the patient is slowly recovering vision.A review of the dhr was unable to identify any deviations or non-conformities relevant to the reported failure.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(6) received a report that, during bypass, a high premembrane pressure was detected for the inspire 8m oxygenator.The perfusionist elected to continue using the device and to complete the procedure.Following the procedure, the patient experienced blindness.It was reported on (b)(6) 2016 that the patient is slowly recovering vision.

Manufacturer Narrative

Mfr report number: the report number indicated in a previously filed follow-up report (follow-up #1, filed february 25, 2016) was incorrect.The report was filed as 9680841-2016-00396 follow-up #1.The correct report number is 9680841-2016-00057.This report and all future reports relating to this complaint will contain report number 9680841-2016-00057.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the inspire 8m hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that, during bypass, a high premembrane pressure was detected for the inspire 8m oxygenator.The perfusionist elected to continue using the device and to complete the procedure.Following the procedure, the patient experienced blindness.It was reported on february 9, 2016 that the patient began slowly recovering vision.The manufacturing record was reviewed and the oxygenator was found to have met specifications upon release.The involved oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection and sem analysis of the returned device did not identify any residual dried blood in the oxygenator or heat exchanger fiber bundles.Visual inspection of the arterial filter identified residual dried blood.The results of an sem analysis indicates that the deposits are compatible with activated platelet deposition.Analysis of the pump record with a predictive model confirmed that a significant increase of the premembrane pressure occurred 35 minutes after the procedure began.As no blood residues were found in the oxygenator and heat-exchanger fiber bundle, sorin group (b)(4) identified that the high pressure phenomenon was of transient type.Although the frequency of this type of issue is low, sorin group (b)(4) has initiated a capa to investigate possible triggering factors.

Manufacturer Narrative

H.10: the correct event date is (b)(6) 2016, not (b)(6) 2016 as indicated in the initial report.Section b.3 updated accordingly.As per e-mail from jaladhi, vijai d dated 11 feb 2021 livanova is submitting this follow-up in replacement of the already provided medwatch 9680841-2016-00396 due to the fact that the reference provided was incorrect.

Event Description

See initial submitted outside of reliance (mfr 9680841-2016-00057).

• Brand Name: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 5458214
• MDR Text Key: 38960088
• Report Number: 9680841-2016-00057
• 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,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: IN00092
• Device Lot Number: 1509070021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: 05/10/2016; 05/10/2016; 05/10/2016
• Supplement Dates FDA Received: 02/15/2021; 03/04/2016; 06/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Weight: 113