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

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

Device Problem Blocked Connection (2888)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Date of event is unknown sorin group (b)(6) manufactures the d902 dideco lilliput phisio oxygenator.The incident occurred in (b)(6).Since the oxygenator is blood contaminated, the involved device has not been requested for return to sorin group (b)(6) for investigation if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Blood contaminated.

Event Description

Sorin group italia has received a report that, during a procedure, the manifold line of the d902 dideco lilliput phisio oxygenator was not working.Medical team elected to change-out the oxygenator.There is no report of any patient injury.

Manufacturer Narrative

Review of complaints database revealed no other similar cases notified for batch concerned from the market.Livanova started a follow-up activity with submitter to find out specific phase when change-out of the unit was conducted and its duration.However, no reply was given.Considering the intended use of this port (i.E.Monitoring the gas exchange performances), it is reasonable to assume that change-out of the unit was conducted in the early phase of surgery when taking the first arterial blood sample (failed attempt).Based on results of investigation of previous similar events, the most probable root cause of the issue was a damaged valve insert body.The valve insert regulates the valve opening.If the valve insert is damaged, (i.E.Due to handling when manually positioned on silicone membrane valve in manufacturing line or due to excessive screwing force of male luer lock cap applied during assembly phase), the valve cannot be opened and no flow is possible a non-conformity report has been opened to investigate the assembly of the one-way valve.The risk associated is in the acceptable region.At the moment 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 D902
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IN 41037
• 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: 12867993
• MDR Text Key: 281203290
• Report Number: 9680841-2021-00034
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)240330(10)2104020002(11)210402(240)05320
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/25/2022

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: 03/30/2024
• Device Model Number: D902 PH.I.S.I.O.
• Device Catalogue Number: 05320
• Device Lot Number: 2104020002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1