MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

Device Problem Restricted Flow rate (1248)

Patient Problem Infarction, Cerebral (1771)

Event Date 02/24/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: visual inspection shows evidence of clotting.Performance analysis: pressure integrity testing shows no internal or external leaks when run at 3 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.The device was sent to a blood lab for performance testing; 273 mmhg blood side pressure drop was recorded.Reason for return not confirmed for flow issues.Conclusion not yet available ¿ evaluation in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported after heparin administration, an act of 600 seconds or more was confirmed and the sump was started.Cardiopulmonary bypass was started approximately 10 minutes after the start of sump.Immediately after cardiopulmonary bypass had begun, the flow remained around 1 l / min and cardiopulmonary bypass was unable to be established.The oxygenator, cardiopulmonary bypass circuit and cardioplegia circuit were all replaced.However, even using the new oxygenator, the issue persisted.Following, a non-medtronic oxygenator was used and cardiopulmonary bypass proceeded as normal.Patient cerebral infarction was reported.Medtronic has requested additional information in relation to the complaint event and patient history, but no response has been received to date.

Manufacturer Narrative

D.Suspect medical device expiration date, device mfg date, lot# corrected from the initial report, to 2020-06-11, 2018-06-11, (b)(4) respectively.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

Investigation conclusion: it is suspected the restricted flow experienced by the customer may be related to the patient clinical condition at time of bypass including, platelet or possibly lipid induced high trans-membrane pressure excursion event, temperature extremes or variability in heparin potency causing a faster decline in anti-coagulation than anticipated.The device history record was reviewed; no abnormalities were documented during the manufacture of this product to indicate the product did not meet manufacturing specifications which would cause or contribute to the reported occurrence.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: FUSION HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8449987
• MDR Text Key: 139800588
• Report Number: 2184009-2019-00009
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00643169178168
• UDI-Public: 00643169178168
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/11/2020
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: 13262486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR