MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888211216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Pneumonia (2011); Asystole (4442); Unintended Radiation Exposure (4565)

Event Date 04/07/2022

Event Type  Injury  

Event Description

According to the reporter, nurses from the dialysis ward came to perform plasmapheresis on the patient.Upon rinsing the dialysis catheter which was most likely during final saline/heparin flush, the patient had become unwell and continued to develop asystole.Resuscitation procedures including chest compression, and adrenaline 1mg had to be initiated.The patient's condition stabilized after about 3-4 minutes.The plasmapheresis had just been performed.The patient had already undergone multiple plasmapheresis through the same catheter without any problems.A cardiologist performed ultrasound and found that there was air in the right ventricle of the heart.Air through the catheter was believed to be the source of the air embolism.The doctor immediately came to the scene, checked the dialysis catheter, the clamps were in place and closed, no air was visible in the catheter, and blood could normally be aspirated from the catheter.Chest compression and adrenaline 1mg were required due to the air embolism.The air embolism was resolved.The hcp (health care professional) did not think that the event was related to a catheter malfunction, but it was not possible to fully verify this.The patient already had pneumonia before the event.Worsening and reactivation of pneumonia after the event could be caused by the resuscitation.Antibiotics were required due to the pneumonia and the pneumonia was resolved.The patient required hospital admission or prolonged hospitalization on unspecified dates as a result of the reported event.The transfer from the icu (intensive care unit) to the ward was delayed by approximately 3 days.Most likely, no other patient injuries believed to be related to this event however, this could not be fully confirmed yet.No air alarms by the plasmapheresis machine noted during plasmapheresis therapy.No abnormalities noted with the bloodlines used for this therapy.In addition to the plasmapheresis machine, no other products utilized with the device.No other defects/damages found on the catheter.No issue/malfunction noted with the catheter that necessitated taking it out.The catheter was explanted to avoid any further problems.The catheter was not repaired, it was not replaced, there was no leak, tego was not utilized and there was no luer adapter issue.There was no blood loss and blood transfusion was not required.The patient was in stable condition at the resolution of the reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: b5, g3.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

According to the reporter, nurses from the dialysis ward came to perform plasmapheresis on the patient.Upon rinsing the dialysis catheter which was most likely during final saline/heparin flush, the patient had become unwell and continued to develop asystole.Resuscitation procedures including chest compression, and adrenaline 1mg had to be initiated.The patient's condition stabilized after about 3-4 minutes.The plasmapheresis had just been performed.The patient had already undergone multiple plasmapheresis through the same catheter without any problems.A cardiologist performed ultrasound and found that there was air in the right ventricle of the heart.Air through the catheter was believed to be the source of the air embolism.The doctor immediately came to the scene, checked the dialysis catheter, the clamps were in place and closed, no air was visible in the catheter, and blood could normally be aspirated from the catheter.Chest compression and adrenaline 1mg were required due to the air embolism.The air embolism was resolved.The hcp (health care professional) did not think that the event was related to a catheter malfunction, but it was not possible to fully verify this.The patient already had pneumonia before the event.Worsening and reactivation of pneumonia after the event could be caused by the resuscitation.Antibiotics were required due to the pneumonia and the pneumonia was resolved.The patient required hospital admission or prolonged hospitalization on unspecified dates as a result of the reported event.The transfer from the icu (intensive care unit) to the ward was delayed by approximately 3 days.Most likely, no other patient injuries believed to be related to this event however, this could not be fully confirmed yet.No air alarms by the plasmapheresis machine noted during plasmapheresis therapy.No abnormalities noted with the bloodlines used for this therapy.In addition to the plasmapheresis machine, no other products utilized with the device.No other defects/damages found on the catheter.No issue/malfunction noted with the catheter that necessitated taking it out.The catheter was explanted to avoid any further problems.The catheter was not repaired, it was not replaced, there was no leak, tego was not utilized and there was no luer adapter issue.Unspecified cleaning agent was used on the device.There was no blood loss and blood transfusion was not required.The patient was in stable condition at the resolution of the reported event.

Manufacturer Narrative

Correction: g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number) additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was an adverse event with no alleged device issue.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14256655
• MDR Text Key: 290445287
• Report Number: 3009211636-2022-00105
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125377
• UDI-Public: 10884521125377
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888211216
• Device Catalogue Number: 8888211216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/02/2022; 07/07/2023
• Supplement Dates FDA Received: 05/17/2022; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG