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

Model Number BB811

Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

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 it was noted that there was decreased flow.No problems were reported during priming and at the start pump ran with full flow possible with normal pressures.Immediately afterwards there was decreasing flow.Rpm's were increased, after minute flow decreased, the perfusionist then increased rpm's but saturation declined.At max rpm but perfusionist could not turn more than 2.2 liter.Arterial pressure after oxy was 120mmhg.Negative pressure max 10mmhg suction.Saturation patient continued to decline and anesthesiologist had to ventilate patient again.The device was replaced.There was no adverse effect to the patient.

Manufacturer Narrative

Complaint was not confirmed for restricted flow.There were no visual anomalies identified during the analysis of the returned device.Testing of the returned device indicated that the device primed with no issues and the circuit operated from 0 to 7 lpm with approximately 120mmhg back pressure with no flow issues.Testing of the returned device found the blood phase pressure drop was 174 mmhg at a flow rate of 7 l/min 1:1 ratio (7lpm blood & gas flows).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.The cause for this occurrence is unknown.Potential contributing factors include patient or clinical condition at time of bypass, temperature at the time of bypass initiation, or variability in heparin potency causing a faster decline in anti-coagulation than anticipated.This investigation was completed with the information that was provided, if additional inf ormation is received, this investigation will be reopened if deemed necessary.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 Description

Medtronic received information that during use of a fusion oxygenator it was noted that there was decreased flow.No problems were reported during priming and at the start pump ran with full flow possible with normal pressures.Immediately afterwards there was decreasing flow.Rpm's were increased, after minute flow decreased, the perfusionist then increased rpm's but saturation declined.At max rpm but perfusionist could not turn more than 2.2 liter.Arterial pressure after oxy was 120mmhg.Negative pressure max 10mmhg suction.Saturation patient continued to decline and anesthesiologist had to ventilate patient again.The device was replaced.There was no adverse effect to the patient.

• 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: 9810599
• MDR Text Key: 183104416
• Report Number: 2184009-2020-00014
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention