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

Catalog Number V900-144

Device Problem Break (1069)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

Sorin group italia received a report that pediatric cannula broke after the procedure was completed.There is no report of any patient injury.

Manufacturer Narrative

D.4.The expiration date refers to the sterile finished product.The complained paediatric cannula, venous (catalog number v900-144) is not distributed in the usa, therefore the udi is not applicable.The cannula item v132-16 is similar to the paediatric cannula, venous v900-144, which is distributed in the usa, for which the device identifier is (b)(4).G.5.The product item v900-144 is not distributed in the usa, but it is similar to the item v132-16, which is distributed in the usa (510(k) number: k890980 ).H.4.The device manufacture date refers to manufacture date of the sterile, finished product.H.10.Sorin group italia manufactures the paediatric cannula, venous (catalog number v900-144).The incident occurred in united kingdom.The involved device has been requested for return to sorin group italia for investigation.According to follow up with the customer, the cannula was clamped with the same instrument as usual as well as was used as usual.The broken part was noticed on unclamping post bypass if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

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.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.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 initial report.

• Brand Name: PAEDIATRIC CANNULA, VENOUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 121 nord, 86; mirandola (modena)
• 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: 17078926
• MDR Text Key: 317590531
• Report Number: 9680841-2023-00023
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 08033178006156
• UDI-Public: (01)08033178006156(17)241117(10)2111190009(11)211119(240)V900-144
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/29/2023

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 Catalogue Number: V900-144
• Device Lot Number: 2111190009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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