MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96830-114

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219)

Event Date 05/10/2013

Event Type  Death  

Manufacturer Narrative

Literature information authors: reinis balmaks, kari e.Sufficool, frances v.White, melissa m.Byrge, nikoleta s.Kolovos journal name: the international journal of artificial organs year: 2013 issue #: 36 title of article: extracorporeal membrane oxygenation cannula malposition in the azygos vein in an infant literature reference: 10.5301/ijao.5000225.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding an aberrant extra-corporeal membrane oxygenation (ecmo) cannula placement in the azygos vein in a child outside the neonatal period.The patient was treated for aspiration pneumonia and chronic lung disease exacerbation.On the seventh day of admission she had improved from a respiratory standpoint, however she developed progressive watery diarrhea.A day later, she became febrile, tachycardic, with heart rate reaching 200 beats per minute, and listless.Ultimately, she became pulseless and apneic; cardiopulmonary resuscitation was initiated.After endotracheal intubation, ten minutes of chest compressions and intraosseous resuscitation, she regained spontaneous circulation.She was then transferred to the pediatric intensive care unit for ongoing inotropic and ventilatory support.The initial post-resuscitation capillary blood gas showed ph 6.63, pco2 81mmhg, calculated bicarbonate 8 mmol/l, and base deficit -29 mmol/l.The first documented central venous lactate was 11.1 mmol/l.For hemodynamic assessment, transpulmonary thermodilution technique with picco monitor was used.Despite aggressive inotropic and fluid resuscitation, she continued to have low cardiac output.Echocardiogram demonstrated dilated right ventricle with half-systemic pressure, but preserved systolic function and otherwise normal heart anatomy.Limited neurologic examination was reassuring, with equal pupils reactive to light, therefore the decision was made to proceed with venoarterial ecmo support.She underwent right carotid arteriotomy and right internal jugular venotomy for cannulation with 10f and 14f cannulae bio-medicus cannulae respectively.During cannulation she experienced another brief bradycardic arrest.With the cannulae in place, the venous drainage appeared to be inadequate, as evidenced by negative venous line pressures and low pump flow.The venous cannula was re-sutured under tension with temporary improvement.The flow continued to be in a range of 70 to 80 ml/kg per min and did not improve after volume expansion with intravenous fluid boluses.It was clinically suspected that abdominal distention caused by ischemic bowel injury was impeding the venous return; this was also supported by invasive hemodynamic monitoring prior to ecmo indicating insufficient preload.On chest x-ray, the venous cannula was noted to be in a rather high, but overall satisfactory position.Overnight the patient developed absence of brain stem reflexes; following discussions with the family they elected to redirect care and discontinue extracorporeal support.The patient died shortly thereafter.Autopsy revealed panlobar pneumonia and multi-organ ischemic injury.The distal portion of the venous cannula was found to bypass the superior vena cava and enter the azygos vein with lateral hole of the cannula located at the level of caval-azygos junction.

Manufacturer Narrative

Additional information b5: medtronic received additional information that none of the adverse events mentioned were directly related to the medtronic devices.None of the medtronic devices mentioned in this article are available for evaluation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of an aberrant extra-corporeal membrane oxygenation (ecmo) cannula placement in the azygos vein resulting in a patient death, as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.A clinical review was completed with medtronic medical safety and the review concluded that there was no allegation that the patient death was related to the bio-medicus nextgen pediatric venous cannula.There were no device malfunctions reported and the venous drainage issues in the literature article were most likely caused by the malpositioning of the cannula.Additionally, during the time period reported in the literature article, the bio-medicus nextgen pediatric venous cannula were only ¿intended for use up to 6 hours¿ (refer to instructions for use (ifu)) and use beyond 6 hours would be considered off-label.The device history record could not be reviewed as no lot number was provided.Trend for issues with this device are monitored.Correction d5 oper of devi: this field has been updated to health care porfessional.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO-MEDICUS FEMORAL VENOUS 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15127698
• MDR Text Key: 296838517
• Report Number: 2184009-2022-00191
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 96830-114
• Device Catalogue Number: 96830-114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 09/16/2022
• Supplement Dates FDA Received: 08/29/2022; 09/30/2022
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 1 YR
• Patient Sex: Female
• Patient Weight: 9 KG