MAUDE Adverse Event Report: PERFUSION SYSTEMS "BIO-MEDICUS FLOW PROBE, ADULT"; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Model Number DP-38

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 08/26/2020

Event Type  Death  

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 custom tubing pack, a crack was found in the dp-38 flow probe cell, and blood leaked.The cell was removed and changed to a tube, and an ultrasonic flow meter was used instead.When the extra corporeal membrane oxygenation (ecmo) circuit was replaced, oxygen became poor and blood pressure dropped, which resulted in severe bradycardia.Chest compression was required for about 1 minute.To improve hypoxemia, steroid pulse therapy, draining, and pulmonary care were performed, but the improvement was poor.A 250 ml of blood transfusion (map) for circuit replacement followed by 60 ml of ffp.The ecmo was removed on (b)(6) 2020, but the patient died about 1 hour after removal of the ecmo due to hypoxemia.It was unknown whether the bleeding and circuit replacement was direct cause or not.Additional information: the patient was born by emergent caesarean section at (b)(6) of gestation due to foetal hydrops and pleural effusion.After birth, intensive care including artificial respiration management was performed, but introduction of veno-venous (v-v) ecmo was required 1 day after birth because the patient¿s respiratory condition deteriorated.

Manufacturer Narrative

Additional information received reported that the device was not scrutinized before use, but it was confirmed that there was no leak through water.It was asked but unknown whether there were there any cracks noted in the cell during inspection.The cell been in use for about 20 hours when the leak occurred.Phone number updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic investigation: medtronic received information that during use of a custom tubing pack, a crack was found in the dp-38 flow probe cell, and blood leaked.The video provided by the customer showed evidence of blood leaking near the tubing connection of the bio-probe.The information provided indicated the leak did not occur until 20 hours into use.Under this guidance, the fda is allowing temporary limited modifications to the indications of certain fda-cleared or fda-approved cardiopulmonary devices without prior submission of premarket notification.These modifications are allowed, in light of the public health emergency, when they do not create an undue risk.This indication modification is in effect for the duration of the public health emergency related to covid-19, as declared by the department of health and human services (hhs).The customer provided significant detail regarding the patient initial condition, use conditions, details about the device and the resulting harms.As the device was discarded, medtronic was unable to review the device and identify a root cause.The leak may be related to a tubing connection issue or damage caused by a collision or other traumatic event.Discussion with manufacturing engineers and a dhr review did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported incident.There have been no product or process changes related to this device which would cause or contribute to the reported incident.Medtronic cannot confirm or deny if the length of the procedure contributed to the reported incident or which harms are related to the device and/or its replacement.A clinical review of product event was conducted to ensure appropriate assessment and actions are taken.Based upon this assessment, there are no new risks associated with the use of this device as no new failure modes or use conditions of the system have been observed.After investigation and without the device for analysis the root cause of this complaint could not be determined.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Notification to manufacturing personnel was performed to spread awareness on this event.Risk management documentation was reviewed, and no updates were determined necessary.Medtronic will continue to monitor for future occurrences and trends.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: "BIO-MEDICUS FLOW PROBE, ADULT"
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10565564
• MDR Text Key: 207885089
• Report Number: 2184009-2020-00051
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• PMA/PMN Number: K132730
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DP-38
• Device Catalogue Number: DP-38
• Device Lot Number: 13307106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 1 DA
• Patient Weight: 3