MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL. PUREFLEX ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number RA20-1BB

Device Problem Contamination (1120)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: sorin group italy manufactures the pureflex arterial cannula.The incident occurred in (b)(6), france.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.

Event Description

Sorin group italy received a report that before cannulation a foreign body was detected in a pureflex arterial cannula.The issue occurred under aortic valve replacement on a 49 years old patient.Medical team elected to replace the cannula.

• Brand Name: PUREFLEX ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL.; strada statale 12 nord 86; mirandola 41037 ; IT 41037
• 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: 19150884
• MDR Text Key: 341254888
• Report Number: 9680841-2024-00012
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803317801690
• UDI-Public: (01)00803317801690(17)260928(10)2309290117(240)RA20-1BB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180979
• 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
• Report Date: 04/22/2024

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: RA20-1BB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2023
• 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