MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 17 FR ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96570-117

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 04/27/2015

Event Type  Injury  

Manufacturer Narrative

This literature article was published in april 2015.Citation doi: 10.1177/0267659115584785.Lead author: s hussain.Journal title: article title: lessons from aviation - the role of checklists in minimally invasive cardiac surgery; issue:31; publish date: april 27, 2015; cannula model 96570-117 was entered as a placeholder as specific model and lot numbers were not provided.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding an adverse event during a minimally invasive cardiac surgery that resulted in a multi-disciplinary review of intra-operative errors and the creation of a procedural checklist.All data was collected from a single center related to one procedure.The study population included 1 patient; a (b)(6) year-old female with recurrent cerebrovascular events.The patient was found, upon further investigations to have an atrial septal defect (asd).The patient underwent general anaesthesia and was placed in a 30° left lateral decubitus position.The system contained medtronic cannulae (model and lot numbers not provided).The 17-fr cannula in the superior vena cava (svc) was placed outside the surgical field, which was an adaptation for the minimally invasive procedure and different from the routine for conventional cardiac surgical cases.This increased the risk of the cannula being unattended and unintentionally manipulated.During skin closure, the patient developed acute hypotension refractory to vasopressors and fluid resuscitation.This progressed to pulseless electrical activity requiring sternotomy and open cardiac massage, with the finding of a severely under-filled heart.An immediate source of bleeding could not be identified, but it was quickly discovered that the patient had lost her blood volume from an unclamped svc cannula tubing into the cardiopulmonary bypass (cpb) reservoir and discarded.The patient underwent cardiac massage for 7 minutes and was resuscitated with crystalloid, blood and drugs (epinephrine, phenylephrine and vasopressin).Cpb was restarted with central cannulation.After normalizing the biochemical and hemodynamic parameters, cpb was weaned-off and the patient was transferred to the cardiac surgery recovery unit where systemic hypothermia was implemented for 24 hours.Patient had a slow convalescence and was discharged after 10 days on the ward, with a total hospital stay of 14 days.On follow-up at six weeks and at four months, the patient remained asymptomatic.There were no device malfunctions noted.No additional adverse patient effects were reported.

• Brand Name: BIO-MEDICUS NG 17 FR 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: 8964807
• MDR Text Key: 156609490
• Report Number: 2184009-2019-00055
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96570-117
• Device Catalogue Number: 96570-117
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR