MAUDE Adverse Event Report: PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 77108

Device Problem Fracture (1260)

Patient Problem Hypovolemia (2243)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic is unable to determine the root cause of the issue at the current time without the return of the product.Medtronic is continuing to pursue additional information and has made requests for the return of the device if it is removed from the patient.From other; device has been requested but has not been returned yet.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a dlp paediatric one-piece arterial cannula approximately 27 minutes after first use of the cannula the anaesthetist noticed the presence of blood coming from a split in the cannula.A cupula was implemented under the canula to recover lost blood.It is unknown if the cannula was replaced.The patient experience hypovolemia.

Manufacturer Narrative

Visual analysis: visual inspection shows evidence of a crack in the fitting/connector at the interface between the body and the connector.Performance analysis: during the cleaning process there was a leak observed from the connector/cannula body interface.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7316323
• MDR Text Key: 101621881
• Report Number: 2184009-2018-00006
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20613994879947
• UDI-Public: 20613994879947
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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 Expiration Date: 08/31/2020
• Device Model Number: 77108
• Device Catalogue Number: 77108
• Device Lot Number: 2017080688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2017
• 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