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

Model Number 77008

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of a dlp pediatric one-piece arterial cannula, extreme pressures were observed in the arterial line.During a surgery for a three month patient planned for a trans atrial closure of a ventricular septal defect (vsd) extreme pressures were observed in the arterial line at start of extracorporeal circulation (ecc).After cannulation the line was tested, normal pressures were observed with a rise to approximately 85 mmhg that then decreased to 45 mmhg.Ecc was then started.Full flow was achieved at 0 ,86l/min, pressures in the arterial line then rose quickly to 460mmhg.The arterial line was inspected for kinking or incorrectly placed claps but none were found.The surgeon then adjusted the canula position.No decrease in arterial line pressures was observed.After 5 minutes the customer went off bypass to be able to adjust the cannula position to a greater extent and to examine the aortic arch for dissection.No dissection was found and the cannula position was adjusted again.Ecc was again started but the same high pressures were observed.The customer therefore went off bypass again and changed the arterial cannula to another 8fr canula of the same make.At the third start of ecc expected pressures of approximately 345mmhg were observed.The second replacement cannula (77008) was used to complete the case.No obvious damage could be observed in the cannula and the customer stated cannula placement could be the cause of the problem, but they were unable tp exclude the possibility of a defective canula.The customer stated that no patient damage occurred as a result of this issue.Additional information: there was no damage or blockage to the cannula body or tip.The duration of cannulation was normal.Mannitol, banked blood, albumin, tribonat and ringer acetat were used during prime.The patient had not previously been on heparin or other anti-coagulant therapy before the surgery.Anti-coagulation was assessed using an act instrument.624 sec.When surgery started.No buildup was noted on the filter media.The surgery took 39 minutes and the act were between 624 ¿ 836 sec.During the whole procedure there are two potential lot numbers for the cannula; 2020090160 or 2020050213.

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of any damage.Dimensional/performance testing will be done by the supplier.Reason for return was undetermined.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: after investigation the complaint is unconfirmed for high pressures in the arterial cannula.Visual inspection found no signs of damage to the returned cannula.The cannula was returned missing the obturator.A dimensional check was performed on the returned cannula body for overall length using a calibrated ruler.The cannula body length was then taken using the referencing dimensions on the device master record drawing.The results found that the cannula body length was within the tolerances given.Functional testing was then performed.The cannula was attached to a water source with air set at 1 psi.As the original obturator that was packaged with the cannula was not returned, a component in inventory was pulled to perform the functional flow test.Water line was then unclamped, and water was observed flowing up through the cannula, with the cannula held at a horizontal position for 15 seconds.No leaks were observed.There was no damage observed to the cannula and performance testing indicated that the cannula functioned as intended.It is unknown what may have caused this occurrence.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from may 2020 through june 2021 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.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: PED. ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11840513
• MDR Text Key: 252242098
• Report Number: 2184009-2021-00039
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K024069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

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: 77008
• Device Catalogue Number: 77008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 06/30/2021
• Supplement Dates FDA Received: 06/30/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO
• Patient Weight: 6