MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03704

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The inspire 6f m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (item in00993, lot 2003100075).The sterile convenience pack 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 complained inspire 6f 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 050702) is 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 6f m hollow fiber oxygenator.The incident occurred in (b)(6).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 and it has not yet been returned.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, the po2 values were low.The medical team elected to change-out the oxygenator.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

The complained inspire oxygenator 6f has been returned to livanova for investigation and it has been subjected to gamma-ray decontamination as per livanova procedure on blood contaminated goods.Visual inspection of the returned oxygenator found no problem.To investigate the reported failure (low oxygenation values), the device capacity to transfer oxygen and remove carbon dioxide has been tested as per relevant iso standards.O2 transfer and co2 removal of the returned oxygenator were below expected performance for a brand-new device.It should be noticed that returned oxygenator should be considered an over stressed device due to previous clinical usage, decontamination treatment, transportation and storage conditions which imply a certain level of biological deposition on the fiber bundle possibly occluding micropores on the membrane.Accordingly, during the performance test, water condensation inside microporous fibers was observed suggesting a high level of hydrophilization of the fibers of the returned oxygenator.The hydrophilization of the fibers is most likely ascribable to plasma-protein deposits in the oxygenator affecting the overall gas exchange performance.The customer has also returned some results of the blood gas analysis performed by the clinical team during the surgery.Mathematical analysis of the provided data showed that o2 transfer performances were aligned to clinical maneuvers applied during surgery.In fact, a po2 peak value of 260 mmhg in arterial line was reached and a hemoglobin oxygen saturation (sat o2) percentage of 99,8 % was achieved by keeping constantly the fio2 at 100%.Ifu's of the product recommend increasing the fio2 in case low po2 values are measured in this regard.Manufacturing records and complaint history were reviewed: claimed device was released as conform to specifications and no further similar complaints were recorded for noticed product lot.Moreover, no further similar complaints were recorded for noticed product lot confirming a non-systematic event.Based on all the above, livanova believes that the conditions of returned device did not allow to achieve any significant test results and therefore no root cause could be clearly assessed.Livanova will maintain monitoring the market.

• Brand Name: INSPIRE 6F 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: 10188230
• MDR Text Key: 196241613
• Report Number: 9680841-2020-00010
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Catalogue Number: 03704
• Device Lot Number: 2003100002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1