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

Model Number	V132-20
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
See intial report.

• Brand Name: PAS VENOUS PEDI CANNULAE
• Common Device Name: 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
• Report Number: 9680841-2023-00004
• Device Sequence Number: 20264285
• Product Code: DWF
• UDI-Device Identifier: 08033178004572
• UDI-Public: (01)08033178004572(17)250310(10)2203110026(240)V132-20
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K890980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown