MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS LIFE SUPPORT TM; CATHETER, PERCUTANEOUS

Model Number LS96360-025

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 bio-medicus life support cannula, it was reported that after the perfusionist started the extra corporeal life support (ecls) with the 25 fr.Life-support cannula, that they noticed after a short time that the non-reinforced clamp area behind the connector collapsed completely as a result of a suction phenomenon due to lack of volume of the patient, and the ecls flow dropped from 5.5 l/min to approx.2 l/min.The customer was then able to react quickly and reduced the speed of the console to reduce the suction on the cannula, but then they noticed that the inner lumen at the collapsed part, relaxed relatively slowly.See attached photos.The device was used to complete the procedure.There was no adverse patient effect associated with this event.The patient was not harmed, but the customer stated that if something like this happens unnoticed under a bandage in the intensive care unit, this is of course an immense source of danger, because no one might think directly of a collapsed cannula as the cause of poor ecls flow.Medtronic received additional information that the device was used and the performance was not affected.There was no damage noted to the packaging (outer box, inner packaging or sterile barrier).

Manufacturer Narrative

Conclusion: after investigation at medtronic, complaint is confirmed for the cannula body collapsing based on the photo provided, however, no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed as no lot number was provided.There were no adverse patient effects as a result of this occurrence.Medtronic will continue to monitor for future occurrences and trends.Additional information b5: medtronic received additional information that a centrimag pump was being used during the ecls run.The pump was running at 5500 u/min.The customer did not have a servo or negative pressure regulator.The speed was reduced to 1 l/min when the customer had to react to reduce suction.The act value of the patient at the time of the cannula collapse was 200s.The anticoagulation protocol of the facility was uhf heparin ptt 50-60s, or act180-200s, anti 10a >0,3.There were no clotting identified in the cannula or circuit around the time of the cannula collapse.The cannula was used for va ecmo.The cannula was placed in fem fem va.The length of the cannula tip in the patient was between 40 and 50 cm.The ecls was run for this patient from the initial beginning and going on ecls.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 LIFE SUPPORT TM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17124123
• MDR Text Key: 317906016
• Report Number: 9612164-2023-02578
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201057
• 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: 07/05/2023

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: Health Professional
• Device Model Number: LS96360-025
• Device Catalogue Number: LS96360-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/05/2023
• 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