MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL VENOUS PEDIATRIC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	V132-14
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia has received a report that the tip of the venous pediatric cannula was found cracked during the procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
Patient information were not provided.Sorin group italia manufactures venous pediatric cannula.The incident occurred in (b)(6).At the submission of the case, the customer has provided a picture of the cracked cannula.The involved device has been requested for return to sorin group italia for investigation.Through follow up with the customer livanova learned that cannulae cracked before being suture.After venous cannulae has been put in superior vena cava, surgeon continued to setup venous cannulae for inferior vena cava, the team saw that venous pressure had been dropped and found out cannulae cracked, surgeon changed another cannulae and continued the case.Surgeon also claim to me that he had problem with silicone tube of cannulae before, the tube had been broken when connect with tubing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet received.
Additional Manufacturer Narrative
Livanova received a report stating that a venous cannula was found cracked during the procedure.No patient/user affected.A photo was provided as evidence of the defect showing a longitudinal fracture of the tip.Through follow-up communication with the customer, livanova learned that the cannula was found cracked before being sutured.The unit was requested and not returned to the manufacturing site.The dhr review confirmed the device was released conforming to product specifications.The affected catalogue item is distributed worldwide.A review of livanova complaint databased did not identify any other similar event related to the complained item code excluding any systematic quality deviation.The reported case can be considered isolated and it is unlikely related to a manufacturing issue.The most probable root cause was a mechanical stress occurred during transportation to customer site after the release of the product.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 initial report.

• Brand Name: VENOUS PEDIATRIC CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• 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: 15173887
• Report Number: 9680841-2022-00034
• Device Sequence Number: 6322232
• Product Code: DWF
• UDI-Device Identifier: 08033178004541
• UDI-Public: (01)08033178004541(17)250117(10)2201180092(11)220118(240)V132-14
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: 01/17/2025
• Device Model Number: V132-14
• Device Catalogue Number: V132-14
• Device Lot Number: 2201180092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 12/18/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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