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

Model Number 8888211216

Device Problem Product Quality Problem (1506)

Patient Problem Air Embolism (1697)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, at the end of hemodialysis, the nurse ended dialysis as usual.The table was not set to trendelenburg position because breathing was laborious for the patient.At the same time, the pump alerted about a drug (unknown drug) and noted that the dialysis catheter was accidentally not properly clamped by the nurse and said that the clamps also had an issue wherein they somehow felt a bit and poorly loose and air was then detected in the catheter.The nurse immediately aspirated the air but the patient developed an air embolism and underwent resuscitation.Nothing unusual was observed during dialysis.The catheter was not repaired and had no leak.There was no luer adapter issue.The clamps were said to be moved periodically.Dialysis machine was being utilized with the device.There was no blood loss and no blood transfusion was required.It was said that in order to resolve the air embolism, pea (pulseless electrical activity) rhythm and 3min rosc (return of spontaneous circulation), second resuscitation and rosc 2min were done.Ct (computerized tomography) scan was acquired afterwards and the result was 1-2 hours after the event, there was air in the central venous system.The patient recovered prematurely and was moved to follow-up treatment to another hospital.It was said that based on what they know, the catheter was not replaced after this event and was left to the patient for later use.The customer did not know the status after the patient was moved to another hospital.

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

According to the reporter, at the end of hemodialysis, the nurse ended dialysis as usual.The table was not set to trendelenburg position because breathing was laborious for the patient.At the same time, the pump alerted about a drug (unknown drug) and noted that the dialysis catheter was accidentally not properly clamped by the nurse and said that the clamps also had an issue wherein they somehow felt a bit loose causing it to poorly close and air was then detected in the catheter.The nurse immediately aspirated the air but the patient developed an air embolism and underwent resuscitation.Nothing unusual was observed during dialysis.The catheter was not repaired and had no leak.There was no luer adapter issue.The clamps were said to be moved periodically.Dialysis machine was being utilized with the device.There was no blood loss and no blood transfusion was required.It was said that in order to resolve the air embolism, pea (pulseless electrical activity) rhythm and 3min rosc (return of spontaneous circulation), second resuscitation and rosc 2min were done.Ct (computerized tomography) scan was acquired afterwards and the result was 1-2hours after the event, there was air in the central venous system.The patient recovered prematurely and was moved to follow-up treatment to another hospital.It was said that based on what they know, the catheter was not replaced after this event and was left to the patient for later use and the customer did not know the status after the patient was moved to another hospital.

• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14119340
• MDR Text Key: 289345338
• Report Number: 3009211636-2022-00093
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/04/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male