MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL PUREFLEX® ARTERIAL CANNULA RA20-1SB STRAIGHT COLLAR TIP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number RA20-1SB

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H.10.Sorin group italia manufactures the pureflex arterial cannulae.The incident occurred in germany.Through follow up with the customer, livanova learned that no crack was visible and during the surgery she saw that the cannula was leaking.So that the surgeon changed the cannula.The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 : not yet received.

Event Description

Sorin group italia has received a report that the cannula ra 20-sb straight collar tip presented a transverse fine tear.The issue was identified during procedure there is no report of any patient injury.

Manufacturer Narrative

The involved cannula is intended to be used to return arterial blood from the extracorporeal circuit to the patient and consists of flexible tubing (tapered to a curved or straight flow tip) made of pvc with wire reinforcement.No photos have been provided by the customer, however the unit has been requested for further investigation.The unit returned was inspected and it was observed a transverse tear (around 10 mm) on the body of the cannula, in correspondence with the wire.Furthermore, the leak test highlighted that as a defect area.Then, the condition reported by the customer has been confirmed.The thickness of the affected area is constant and in line with product specification.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The review of the complaint database has identified no similar event both on the ra20-1xx arterial cannulae codes in the last 2 years.Thus, the case is an isolated event.Considering all above facts, reported issue is related to isolated deviation of the manufacturing process enhanced during use at the customer site.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: PUREFLEX® ARTERIAL CANNULA RA20-1SB STRAIGHT COLLAR TIP
• Type of Device: 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; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16874152
• MDR Text Key: 314623460
• Report Number: 9680841-2023-00017
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803317801693
• UDI-Public: (01)00803317801693(17)260124(10)2301250013(240)RA20-1SB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180979
• 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: 08/01/2023

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: RA20-1SB
• Device Lot Number: 2301250013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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