MAUDE Adverse Event Report: PERFUSION SYSTEMS VC2; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 93448

Device Problem Air/Gas in Device (4062)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received information that during use of a vc2 atrial caval venous cannulae, it was reported that after placing cannula in right atrium and connecting it to cardiopulmonary bypass (cpb) machine, there was a lot of air and bubble in cannula.It caused airlock for quite some time.This affected patient's hemodilution and patient's hemoglobin (hb) decreased to 6.The physician placed another cannula in the same area (right atrium) and clamped the troubled cannula to solve the problem.There was no other adverse patient effects associated with this event.Medtronic received additional information that there was patient blood loss.A transfusion was required as a result.Aside from the patients hemoglobin decreasing to 6, no other patient effects due to this incident were detected.Patient was still in hospital but in a stable condition.

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of damage/groove in the connector.The device was pressurized to approxi mately 300 mmhg and placed under water.There was a leak observed from the connector.Reason for return was confirmed for a leak.Additional information b5.Medtronic received additional information that the patient blood loss was about 700-900cc.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

Correction h6.3 (eval code result): a correction has been made to this field.Conclusion: after investigation the complaint is confirmed for damage to the connector resulting in a leak during returned product analysis.The damage to the connector was the only issues identified with the cannula during returned product analysis and it is unknown what may have caused this occurrence of air entering the circuit.The vc2 atrial caval venous cannula reported in this complaint is manufactured and sold without a connector.The connector assembled onto the returned cannula is not a medtronic component, therefore, medtronic is not responsible for the investigation of the issues observed in the connector.It is possible air was entering the circuit through the damaged connector.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received 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: VC2
• 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: 16775127
• MDR Text Key: 313631624
• Report Number: 2184009-2023-00181
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K845045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

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 Expiration Date: 07/22/2023
• Device Model Number: 93448
• Device Catalogue Number: 93448
• Device Lot Number: 2020071107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/18/2023; 06/15/2023
• Supplement Dates FDA Received: 06/08/2023; 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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): Required Intervention