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

Model Number	72120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection of the cannula showed no evidence of any damage/cracks in the connector.The blue cap was removed by the customer and returned loose.The reason for return was undetermined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a select series straight tip arterial cannula, the customer reported that during the installation of the extracorporeal circulation the medical team noticed a leak on the upper part of the cannula.The plug that allows the cannula to be closed while waiting for the connection to the the extracorporeal circulation machine was noted to not be watertight; with the pressure, the patient's blood leaked out at this level. to prevent this, the cannula was clamped while waiting for the connection to the machine. there was no patient impact associated with this event.Additional information: the cannula was not heated or cooled prior to use.The damage was not in the location of the sutures.There was 40-50 ml of patient blood loss as a result of this leak.No transfusion was required as a result of this leak it was clarified that ¿this exposed the careers to an aes¿ meant that "the careers weren't really exposed to blood.The flow of blood was just flowing.".
Additional Manufacturer Narrative
Conclusion: after investigation the complaint is unconfirmed for leak from the upper part of the cannula.There was no observed damage to the device and performance testing indicated that the device functions as intended.The returned device was received with the blue peel away cap already removed from the device.The blue peel away cap is not intended to be watertight and is meant to allow air and blood to vent out of the cannula during priming and connection to the circuit.Visual inspection found the peel tab had been pulled away from the blue cap on the returned device.Additional inspection of the white cap and luer port connection found no signs of short shots, cracks, or splits.Following the component specification drawing for the connector a dimensional check was performed on the outer diameter of several of the connector barbs and overall length on a section of the connector end.Results found that the drawing referencing dimensions taken from the locations on the component were within tolerance.Functional testing was performed on the returned device by attaching the device to 3psi air and submerging the connector under water.No leaking was observed coming from the luer port portion of the connector on the device.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.Trends for issues with this device are monitored.Correction: device evaluation (h2.3), device returned to manufacturer (h2.3.2) and evaluation summary (h2.3.3) have been updated to yes as the device evaluation was provided in the initial report.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.

• Brand Name: SELECT SERIES
• Common Device Name: 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: 13498028
• Report Number: 2184009-2022-00009
• Device Sequence Number: 11825438
• Product Code: DWF
• UDI-Device Identifier: 00643169485938
• UDI-Public: 00643169485938
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K840002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: 72120
• Device Catalogue Number: 72120
• Device Lot Number: 2021050505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG