MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PAS VENOUS PEDI CANNULAE; CANNULA PEDIATRIC VENOUS

Model Number V132-20

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided sorin group italia manufactures the cannula pediatric venous.The event occurred in norway.The issue was discovered before cannulation and going to the machine.Livanova initiated an investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Sorin group italia has received a report that, during insertion of the venous pediatric cannula, it broke the issue was discovered before cannulation and going to the machine.There is no report of any patient injury.According to preliminary information, the cannula was connected to the intermediate piece and the tubing set to the heart-lung machine, as usual.The medical team has filled the cannula with water before use the machine and the water disappeared out of the cannula.When they checked the cannula they found it was broken off.

Manufacturer Narrative

The dhr review highlighted that the involved lot was released as conform according to specifications.The review of the complaints database did not identify similar events on this cannula code in the last 2 years and on the impacted batch (2203110026) out of (b)(4)total units marketed worldwide.Thus, the case can be considered as an isolated event and a systematic deviation of the manufacturing process can be ruled out.The returned unit was inspected and measured according to the procedure used in the production line, where units are 100 % controlled before release, and was found to be conform to specification.The thickness of the affected area was in the range (1.5 +o- 0.3) mm.Unit was checked with production specialists and quality engineers and no defects or deviations were identified that could explain the reported fracture.Based on above, the reported event has been reasonably traced back to an occasional deviation, as a consequence of accidental mechanical stresses / rough handling during the use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: PAS VENOUS PEDI CANNULAE
• Type of Device: CANNULA PEDIATRIC VENOUS
• 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: 16395387
• MDR Text Key: 309993902
• Report Number: 9680841-2023-00004
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 08033178004572
• UDI-Public: (01)08033178004572(17)250310(10)2203110026(240)V132-20
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K890980
• 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: 08/28/2023

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 Model Number: V132-20
• Device Lot Number: 2203110026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 07/30/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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