MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL LILLIPUT (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number D902 PH.I.S.I.O.

Device Problem Medical Gas Supply Problem (2985)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Follow up information with the customer clarified that the change out of the complained oxygenator did took 5-6 minutes.In addition, during the procedure and before oxygenator change-out, the arterial po2 was below than 60mmhg.Sorin group (b)(4) manufactures the d902 dideco lilliput phisio.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.The present report was initially submitted on 14 september, however the third ack failed due to error message: (80) characters are max.The brand name has been shortened and report resubmitted.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, the d902 dideco lilliput phisio oxygenator was not oxygenating as expected.Medical team elected to change-out the oxygenator.There is no report of any patient injury.

Manufacturer Narrative

Livanova has received a report stating that a d902 dideco lilliput phisio oxygenator was not oxygenating as expected during a procedure.There was no impact to patients.Analysis of the pump sheet provided by the customer confirmed the low po2 levels in patient blood.Following oxygenator change-out the po2 levels within specifications were established and procedure was completed with no issue.The complained oxygenator returned to livanova.Simulate use test performed in the laboratory confirmed low oxygen exchange: the device behaved below specifications.However, it shall be considered that after applying a qgas : qblood = 2 : 1, an increase in co2 removal was observed and so2art was within 84.4 % and 92.2 % during the test.A dhr review has pointed out that the product lot was released as conform according to specifications.A livanova complaint database analysis confirmed not other unit of this specific lot was complained for a similar issue thus an isolated event.The complained issue was reproduced.However, it is not possible to have a clear picture of the device performance during the customer event since the oxygenator was investigated after being already used and decontaminated previously.These may have affected device performance.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 possibly related to patient condition, initial blood-gas settings and the involved oxygenator.The risk is in the acceptable region.No corrective action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: LILLIPUT (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• 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: 12475310
• MDR Text Key: 271510769
• Report Number: 9680841-2021-00026
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)230421(10)2004210094(11)200421(240)05320
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K001021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2020
• Device Model Number: D902 PH.I.S.I.O.
• Device Catalogue Number: 05320
• Device Lot Number: 2004210094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1