MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ARTERIAL CANNULA; CANNULA, CATHETER

Model Number A212-65C

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the arterial cannula.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(4) is submitting the report for both sorin group (b)(4) (manufacturer) and livanova usa., inc.(b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.

Event Description

Sorin group (b)(4) has been informed that upon insertion of the arterial cannula, the cap at the end of the cannula fell off and blood flowed onto the surgeon.There is no report of any patient/user injury.

Event Description

See initial report.

Manufacturer Narrative

Sorin group italia manufactures the arterial cannula.The incident occurred in (b)(6).The complained cannula was not made available for investigation.However, the customer has returned 6 units of the same batch of the complained unit (lot 1806200027).In order to better investigate the issue, additional 6 units assembling the same batch of cap of the complained cannula were pulled from livanova stock.Each of the 12 cannula devices were subjected to visual inspection and functional test.Visual inspection did not identify any issue: the caps resulted correctly assembled to the connectors and the caps resulted all conforming to specifications (in detail the presence and the patency of the hole in the cap was confirmed for all caps).Functional test confirmed the devices behave as expected.According to livanova investigation all units resulted correctly assembled and behaved as expected.Ifus of the cannula recommend verifying the patency of the cap and to ensure that the caps are securely tightened before the use of the product.Having no possibility to investigate the complained device, it could not be ruled out that the disconnected cap was related to incorrect assembly.As part of the continuous improvement project, to prevent further reoccurrences, the work instructions to assemble the cap has been updated inserting recommendation and photographic evidence.As the frequency of this type of event is low (improbable), no other action will be undertaken.H3 other text : device not available.

• Brand Name: ARTERIAL CANNULA
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8716670
• MDR Text Key: 179419922
• Report Number: 9680841-2019-00025
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 08033178000642
• UDI-Public: (01)08033178000642(17)210619(10)1806200027
• Combination Product (y/n): N
• PMA/PMN Number: K870826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/19/2021
• Device Model Number: A212-65C
• Device Catalogue Number: A212-65C
• Device Lot Number: 1806200027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 13 MO
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1