MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145040P

Device Problem Disconnection (1171)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 02/25/2023

Event Type  Injury  

Event Description

According to the reporter, on the day of the event, minutes within the patient¿s connection, a disconnection accident between a hemodialysis catheter leg and another manufacturer¿s dialysis bloodline occurred in the chronic hemodialysis sector.The connection itself was carried out in accordance with the best practices, in full compliance with the recommendations of the department.The disconnection involved the dialysis venous line which was the blood outlet line of the extracorporeal circuit, which returned the blood to the patient.As usual, the venous line disconnection was not accompanied by a drop in venous pressure and there was no alarm on thedialysis machine.The extracorporeal circulation (cardiopulmonary bypass) pump continued to run/rotate.There was an estimated blood loss of about 1.5 liters.At this moment, the alarm on the arterial line of the circuit rang, and it was corresponded by a drop in the patient¿s blood pressure.This hemodialysis system alarm fault was inherent in the technique and was well known to dialysis teams.The nurse went to the patient¿s bed, noticed the disconnection and blood loss.The patient then lost consciousness.The emergency procedures were performed, such as, the patient was filled, the dialysis was stopped, and the patient was transferred to intensive care.The patient could be recovered.The patient had a voltage of 14 at the connection.The patient was in a completely normal state and was absolutely not agitated and did not pull on his lines.On the other hand, the patient had a disorder of superior functions and was not able to see a malfunction in his dialysis circuit.It should be noted that the catheter was still on the patient and the blood lines had not been stored.A materiovigilance statement was required to report the dialysis lines and dialysis catheter, although apparently no macroscopic defects had been noted.

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, on the day of the event, minutes within the patient¿s connection, a disconnection accident between a hemodialysis leg catheter and another manufacturer¿s dialysis bloodline occurred in the chronic hemodialysis sector.The connection itself was carried out in accordance with the best practices, in full compliance with the recommendations of the department.The disconnection involved the dialysis venous line which was the blood outlet line of the extracorporeal circuit, which returned the blood to the patient.As usual, the venous line disconnection was not accompanied by a drop in venous pressure and there was no alarm on thedialysis machine.The extracorporeal circulation (cardiopulmonary bypass) pump continued to run/rotate.There was an estimated blood loss of about 1.5 liters.At this moment, the alarm on the arterial line of the circuit rang, and it was corresponded by a drop in the patient¿s blood pressure.This hemodialysis system alarm fault was inherent in the technique and was well known to dialysis teams.The nurse went to the patient¿s bed, noticed the disconnection and blood loss.The patient then lost consciousness.The emergency procedures were performed, such as, the patient was filled, the dialysis was stopped, and the patient was transferred to intensive care.The patient could be recovered.The patient had a voltage of 14 at the connection (which was meant that before dialysis session, the blood pressure was taken, and it was not an intervention/treatment done due to the event).The patient was in a completely normal state and was absolutely not agitated and did not pull on his lines.On the other hand, the patient had a disorder of superior functions and was not able to see a malfunction in his dialysis circuit.It was mentioned that the catheter was still on the patient and the blood lines had not been stored.A materiovigilance statement was required to report the dialysis lines and dialysis catheter, although apparently no macroscopic defects had been noted.

Manufacturer Narrative

Correction: b5 additional information: 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, on the day of the event, minutes within the patient¿s connection, a disconnection accident between a hemodialysis catheter leg and another manufacturer¿s dialysis bloodline occurred in the chronic hemodialysis sector.The connection itself was carried out in accordance with the best practices, in full compliance with the recommendations of the department.The disconnection involved the dialysis venous line which was the blood outlet line of the extracorporeal circuit, which returned the blood to the patient.As usual, the venous line disconnection was not accompanied by a drop in venous pressure and there was no alarm on the dialysis machine.The extracorporeal circulation (cardiopulmonary bypass) pump continued to run/rotate.There was an estimated blood loss of about 1.5 liters.At this moment, the alarm on the arterial line of the circuit rang, and it was corresponded by a drop in the patient¿s blood pressure.This hemodialysis system alarm fault was inherent in the technique and was well known to dialysis teams.The nurse went to the patient¿s bed, noticed the disconnection and blood loss.The patient then lost consciousness.The emergency procedures were performed, such as, the patient was filled, the dialysis was stopped, and the patient was transferred to intensive care.The patient could be recovered.The patient had a voltage of 14 at the connection (which was meant that before dialysis session, the blood pressure was taken, and it was not an intervention/treatment done due to the event).The patient was in a completely normal state and was absolutely not agitated and did not pull on his lines.On the other hand, the patient had a disorder of superior functions and was not able to see a malfunction in his dialysis circuit.The catheter had been in place for more than 1 year (14 months).It should be noted that the catheter was still on the patient and the blood lines had not been stored.A materiovigilance statement was required to report the dialysis lines and dialysis catheter, although apparently no macroscopic defects had been noted.

Manufacturer Narrative

Correction: patient status additional information: b5, d6a, 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.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, 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 55112 ; 7635265677
• MDR Report Key: 17022815
• MDR Text Key: 316253366
• Report Number: 3009211636-2023-00157
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: 10884521158030
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 2028200209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• 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
• Patient Outcome(s): Required Intervention