MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL D 902 DIDECO LILLIPUT PHISIO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 05320

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Sorin group italia has received a report that of a leakage at the lilliput oxygenator arterial outlet during a procedure.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H.10.Sorin group italia manufactures the d 902 dideco lilliput phisio.The incident occurred in (b)(6).The involved device is not available.Attempt to better clarify the complained failure are on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device not available.

Manufacturer Narrative

Through follow-up communication, livanova learned that arterial line connection was not secured with a tie band.Leakage occurred during procedure and change-out of the device was completed within 3-4 minutes.Surgical phase when product was replaced was not specified.Based on collected information, a disconnection of the arterial line was therefore excluded as failure mode.In addition, since no problem was detected during priming phase, a mechanical damage of the oxygenator outlet port was also excluded as cause of the event.Pictures of the device showing the absence of tie band on arterial line tubing was provided.Analysis of complaints database revealed no other similar cases notified for batch concerned from the market.Taking into account above findings, it can be concluded that root cause of reported issue was a faulty connection of the line tubing onto oxygenator outlet port by customer, which was gradually loosened after opening the blood flow rate which is higher than priming flow rate.Circuit connections to oxygenator are charged to customer since affected item is a finished product with no venous nor arterial lines pre-connected.Finally, ifu's of product recommend to verify all connections and secure them with cable tie prior to starting the procedure in this regard.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: D 902 DIDECO LILLIPUT PHISIO
• 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; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17002167
• MDR Text Key: 315926693
• Report Number: 9680841-2023-00019
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100397
• UDI-Public: (01)08033178100397(17)240831(10)2109020044(11)210902(240)05320
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K971877
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05320
• Device Lot Number: 2109020044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1