MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB511

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer (not available for return to medtronic).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use in an extra corporeal membrane oxygenation operation, the customer reported a leak at the interface between the fusion oxygenator and the custom pack tubing.The leak occurred 10 minutes following catheter connection.A 100ml blood loss was reported.A transfusion of one unit of red blood cells was given to the patient.The customer stated that the leak was the main reason for the transfusion.The device was replaced to complete the case.The patient status returned to normal following the transfusion.There was no adverse effect to the patient.

Manufacturer Narrative

Conclusion; it was also reported the leak (100ml) was sufficient enough to require a transfusion.A photograph was provided by the customer showing clear evidence of a tma leak.This type of leak (cracked components) is typically associated with a physical shock possibly encountered during shipping and/or handling.Damage can also propagate throughout use as pressure is applied to damaged components.The damage could also happen as a result of leveraged force applied to the tma which may result in port fracture; this could have occurred during or after the thermistor was attached or if the cord was inadvertently pulled or stepped on.Throughout the assembly process each device is visually inspected and manufacturing controls are in place to ensure that product meets specification prior to the release from the manufacturing facility.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

B5.Desc evt problem and d.Suspect medical device ¿4.Model #/¿catalog #: the complaint device was confirmed to be an affinity nt oxygenator (cb511) and not a fusion oxygenator as reported in the initial mdr.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 in an extra corporeal membrane oxygenation operation, the customer reported a leak at the interface between the affinity nt oxygenator and the custom pack tubing.The leak occurred 10mins following catheter connection.A 100ml blood loss was reported.A transfusion of one unit of red blood cells was given to the patient.The customer stated that the leak was the main reason for the transfusion, as the leak meant that the custom pack joints could not meet the normal extracorporeal circulation of the human body.The device was replaced to complete the case.The patient status returned to normal following the transfusion.There was no adverse effect to the patient.The oxygenator was part of a custom tubing pack: model number: cb1q91r6 lot number: 216666872.

• Brand Name: CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9212705
• MDR Text Key: 195616618
• Report Number: 2184009-2019-00060
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K172626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

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: CB511
• Device Catalogue Number: CB511
• Device Lot Number: 216426918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 01/22/2020
• Supplement Dates FDA Received: 01/07/2020; 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 75