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

Model Number	96820-012
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use, the customer reported a 12 fr bio-medicus pediatric arterial cannula and obturator that had a hole in the wire portion of the cannula.This was found after the cannula was in and the obturator removed.On the cannula, there is a place where the wire portion has been clamped to isolate the leak.The hole will therefore be just above, or toward the connector portion of this cannula.The product was replaced.The patient lost approximately 25ml blood, no transfusion required.No damage to the packaging noted.No negative patient outcome is apparent from this incident at this time.
Additional Manufacturer Narrative
Visual inspection of the returned device noted damage to the device in the coils on the cannula body and it appeared to be indented.Additional inspection under the microscope found what looks like a round hole on the coils in the cannula body tapered area of the coils at the connector end.Dhrs reviewed for the vendor lots identified in this complaint found no non-conformances or deviations associated with this defect.There is no cutting or solvent used in the processing of the product.Supplier stated the devices are 100% leak tested and any damage similar to the complaint device if found, would not be released and the lot would be placed on hold.Complaint history data found no similar occurrences in the past twelve months.Based on the investigation the complaint cannot be confirmed to be either a manufacturing or supplier issue.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, the customer reported a 12 fr bio-medicus pediatric arterial cannula and obturator that had a hole in the wire portion of the cannula.The product was replaced.There was no adverse effect to the patient.The patient lost approximately 25ml blood, no transfusion required.No damage to the packaging noted.
Event or Problem Description
Medtronic received information that during use, the customer reported a 12 fr bio-medicus pediatric arterial cannula and obturator that had a hole in the wire portion of the cannula.The product was replaced.There was no adverse effect to the patient.The patient lost approximately 25ml blood, no transfusion required.No damage to the packaging noted.Additional information provided by the customer: we have a 12 fr bio-medicus pediatric arterial cannula and obturator that has a hole in the wire portion of the cannula.This was found after the cannula was in and the obturator removed.On the cannula, there is a place where the wire portion has been clamped to isolate the leak from the baby.The hole will therefore be just above, or toward the connector portion of this cannula.The case was for dr.Welke, a partial anomalous pulmonary venous return patient.This caused a patient care issue and necessitated changing out the cannula after it was inserted into the aorta and attached to the heart lung machine.No negative patient outcome is apparent from this incident at this time.
Additional Manufacturer Narrative
Analysis of returned device: a tear/split was visible in the cannula body and a leak was observed.The investigation is ongoing.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: PEDIATRIC BIOMEDICUS FEMORAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8797550
• Report Number: 2184009-2019-00047
• Device Sequence Number: 2883254
• Product Code: DWF
• UDI-Device Identifier: 00613994530721
• UDI-Public: 00613994530721
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2019

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: 12/31/2022
• Device Model Number: 96820-012
• Device Catalogue Number: 96820-012
• Device Lot Number: 2018121002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 10/03/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/17/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 15