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

Model Number 8F DUAL PH.I.S.I.O.

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Livanova received a report that, an oxygenator replacement due to poor oxygenation.There is no report of any patient injury.

Manufacturer Narrative

Patient id, age, gender, weight and ethnicity: patient information were not provided.Involved oxygenator is unknown.The brand name was not communicated to livanova.This information will be provided in follow up report if available.Involved oxygenator is unknown.The catalogue number, lot number are unknown.Therefore, also expiry date and udi are unknown.This information will be provided in follow up report if available.Involved oxygenator is unknown.The catalogue number, lot number are unknown.Therefore, also manufacturing date is unknown.This information will be provided in follow up report if available.The incident occurred in (b)(6).The involved device has not yet been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova has received a report about a poor oxygenation experienced by the customer while using a livanova inspire 8f during an emergency case; reportedly there was no impact to patients or users.Follow up with livanova representative was started and it was reported the following additional information: the poor oxygenation phenomenon was detected 2-3 minutes after the surgeon cross-clamped the aorta.The oxygenator replacement took 2 minutes and 20 seconds at blood temp of 33°c.The minimum value measured in arterial line was 47 mmhg and the associated hemoglobin oxygen saturation percentage was 80.9%.The act time measured when the gas exchange performance got worse was 502 seconds.The pump sheet of the case was analyzed and showed that fio2 was increased to 100% when low p02 values were measured in the arterial line, as recommended in the product ifu.Patient discharged in icu without any hemodynamic issue.After two days in sub-icu and after 8 days discharged at home.No information has been provided to livanova suggesting the medical team had investigated the low oxygenation phenomenon before changing the oxygenator out.Therefore, the phenomenon not being investigated, it is not possible to rule out that the poor oxygenation might have been related on how good the blood oxygenation in the patient was before the procedure has started.Since the low oxygenation was observed after 2-3 minutes after the aorta was cross-clamped, it is possible to determine that cardioplegia had not been administered yet to the patient and, therefore, the change took place in a lower critical step of the procedure.Despite requested, the oxygenator has not been received for investigation making it impossible to perform a physical investigation on the claimed device.A complaint database analysis was conducted and revealed that no further complaints have been filed for the mentioned lot on a total of 580 units manufactured.Based on the above and the investigation results of previous similar cases, it cannot be excluded that the most likely root cause of low oxygenation condition was a multifactorial issue, resulting from the interaction between clinical procedure, patient conditions and initial gas-blood settings.Indeed, with the evidence currently gathered, it cannot be concluded that the claimed phenomenon is fully attributable to an oxygenator deviation.No other specific action was currently deemed necessary, livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: INSPIRE 8F DUAL
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 13258091
• MDR Text Key: 286731166
• Report Number: 9680841-2022-00003
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112420
• UDI-Public: (01)08033178112420(17)240927(10)2109290056(11)210929(240)050720
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8F DUAL PH.I.S.I.O.
• Device Catalogue Number: 050720
• Device Lot Number: 2109290056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1