MAUDE Adverse Event Report: PERFUSION SYSTEMS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	BB5U58R12
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: medtronic received information that during use of this tubing pack, one of the lines popped off and sprayed blood all over the bioconsole motor.The customer stated there was nothing wrong with the motor itself, they simple want the inside of the instrument cleaned.Use of the instrument was continued with no resulting adverse patient effect.The blood loss due to the event was less than 100ml.A transfusion was required, but not much blood was used.The customer provided additional information confirming the blood loss reported was a result of a user error only (caused because one of the surgical assistants pulled the venous line off of the reservoir by mistake).Medtronic cannot confirm or deny the complaint of lines popping off as no product has been returned to date.However, per complaint description, customer confirms the disconnection was because of a user error only.After evaluation this complaint was determined to a use-related issue.The device history record was not reviewed as there is no evidence of manufacturing issues with the device.Complaints received from feb 2020 through feb 2021 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.Review of the complaint file indicates sufficient information was provided for completion of this investigation.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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 or Problem Description
Medtronic received information that during use of this bio-console external motor drive instrument one of the lines popped off and sprayed blood all over the motor.The customer stated there was nothing wrong with the motor itself, they simply want the inside of the instrument cleaned.Use of the instrument was continued with no resulting adverse patient effect.Additional information received: the blood loss due to the event was less than 100ml.A transfusion was required, but not much blood was used.The customer provided additional information confirming the blood loss reported was a result of a user error only (caused because one of the surgical assistants pulled the venous line off of the reservoir by mistake).

• Brand Name: NA
• Common Device Name: TUBING, PUMP, 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: 17369807
• Report Number: 2184009-2023-00841
• Device Sequence Number: 11691233
• Product Code: DWE
• UDI-Device Identifier: 00763000274962
• UDI-Public: 00763000274962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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 Model Number: BB5U58R12
• Device Catalogue Number: BB5U58R12
• Device Lot Number: 219724273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2020
• 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 Sex: Unknown