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

Model Number BB811

Device Problems Fluid/Blood Leak (1250); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned complaint device shows evidence of a fiber leak with blood staining on the top and bottom of the oxygenator's fiber bundle.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the fiber bundle.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a fusion oxygenator in an animal research lab, the customer noticed blood dripping from the oxygenator.High pressure was observed, but they were able to use the device to complete the case.There was no human patient involvement, no adverse effect occurred.Additional information: normothermia.Pressure before oxy 500 mmhg post oxy 255 flow 4.8 l/min.The circuit was primed for 1 hour prior to the case, primed with ringer-acetate solution.Heparina administrated during the case was 25000iu.There was no visible damage to the device.No visible air in the system.¿increased pressure from the beginning of the case over 5 minutes.¿normal flow of 4.5-5.0 l/min and pressures normal during the case.It as asked but unknown if the animal had previously been administered heparin or other anti-coagulant therapy.Animal was not used for research before.The pump configuration was roller.No cell saver was used, and suction use was limited.¿no massive amount of air entered the circuit from either suckers or vents.Act plus level higher than 600 during the case.Perfusion records were refused as the case related to an animal.

Manufacturer Narrative

Correction required: this event was reported in error for high pressure issue.This event was for an animal study where the issue is more likely to be for fiber leak which is not a reportable event.Result from investigation also indicates the complaint was not confirmed for the fusion hfo high pressure.Analysis of the returned device was unable to replicate the reported incident.The returned fusion hfo resulted in a blood side pressure drop of 176 mmhg at a flow rate of 7 l/min.This is used as an indicator for device performance from a restricted flow or high pressure drop perspective, and the results were as expected.Complaint was confirmed for a fiber bundle leak.Analysis of the returned device found the leak originated from a fiber within the fiber bundle.The device history record was reviewed; devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.This type of leak rarely occurs because the fusion hfo is 100 % leak tested during production and any leaks identified during testing are discarded, this device was found to be acceptable during production.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: 11911697
• MDR Text Key: 264945723
• Report Number: 2184009-2021-00047
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K183490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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
• Device Operator: No Information
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other