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

Model Number 96820-008

Device Problem Cut In Material (2454)

Patient Problem Blood Loss (2597)

Event Date 01/11/2014

Event Type  malfunction  

Event Description

Medtronic received information that during a veno-arterial extracroporeal membrane oxygenation (ecmo) procedure, using this arterial bio-medicus (8f) cannula, the cannula appeared to be leaking.The customer reported that when the cannula was fixed with a silk tie per normal procedure the tie appeared to cut into the plastic of the lumen of the cannula.The cut was between the metal reinforced rings and reduced the lumen.There was no interruption to blood flow, but a small bead of blood appeared on the tie, which suggested that the integrity of the wall of the cannula had been breached.A decision was made to change the cannula.The patient was taken off ecmo for less than two minutes and suffered no adverse effects.The cannula was replaced and ecmo recommenced.On securing the second arterial cannula a band was placed around the cannula, and the suture was then tied onto the band so that any tightening or pressure was not applied directly onto the body of the cannula.It was reported that the surgeon is not sure of the cause of the leak but thinks the tie may have been inadvertently tied too tight.The facility is reviewing their procedure regarding securing arterial cannula.The device was discarded and will not be returned for analysis.

Manufacturer Narrative

Conclusion: available information indicates that the product was discarded and will not be returned to medtronic.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic could not obtain the patient information.If additional information is received medtronic will submit a follow up report.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEDIATRIC BIOMEDICUS FEMORAL 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): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3761597
• MDR Text Key: 4420522
• Report Number: 2184009-2014-00024
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K872033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 96820-008
• Device Catalogue Number: 96820-008
• Device Lot Number: 2012020221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2012
• 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