MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HFO CARMEDA COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB811

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been primed.Pressure integrity t esting 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 the blood lab for ease of prime testing, the results are as reported below: initial prime time (time of complete removal of air @ 4 lpm) = 21 seconds.Bubbles observed after 10 min w/150 mmhg back pressure @ 7 lpm = no reason for return was not confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use during priming of this fusion oxygenator, it was reported that the customer was unable to perform the deairing process during priming, there was a big air bubble that could not be eliminated with any maneuver and a small leakage at blood outlet port was observed.The oxygenator was replaced for the procedure.There was no patient involvement so no adverse patient effects occurred.

Manufacturer Narrative

Conclusion: complaint not confirmed for the fusion oxygenator's difficulty removing air and the small leak from the blood outlet.The issues were not verified during analysis of the returned device.Pressure integrity testing showed no internal or external leaks.During ease of prime testing no bubbles were observed after 10 minutes with 150 mmhg of back pressure at 7 lpm of flow.The customer-provided video appears to show an air bubble at the top of the device, which could be caused by the water hammer affect.Air can generate due to a negative pressure spike, which results in air pulled across the fiber membrane.The fiber variation in porosity can influence this affect.The instructions for use recommend a co2 flush of the circuit prior to priming may improve ease of priming.Review of this unit¿s device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.This device passed all testing and inspections during manufacturing.The root cause is unknown, but potentially related to this water hammer affect.There were no patient/clinical safety issues reported.Trends for issues with this device are monitored.B5 additional information: medtronic received additional information stating that there was no damage to the packaging or other contents within the package.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 HFO CARMEDA COATED
• Type of Device: OXYGENATOR, 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: 13730487
• MDR Text Key: 289227212
• Report Number: 2184009-2022-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/08/2022
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 220928489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1