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

Model Number 8888145016

Device Problems Insufficient Flow or Under Infusion (2182); Migration (4003)

Patient Problems Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2023

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

According to the reporter, the tunneled line (which meant central venous catheter) was dislodged following the commencement of hemodialysis (hd) at the peripheral unit of another facility when the patient turned on the side.The flow stopped and was unable to rinseback.It was stated that the nurses were unable to return the blood in the circuit to the patient, and this meant that the flow from the line ceased, and the nurses were unable to get any further flow.Upon presenting to the facility, the on-call registrar was contacted.As a remedial action, the patient was transferred to ward 108 of the reporting facility, where the line had been removed and a temporary line was inserted.The patient allowed the removal of the tunneled line but would not accept a replacement line and was discharged against medical advice.The blood was safe at this time, the potassium was 4.4 mmol/l (millimoles per liter), and the urea was 19.5 mmol/l.It was stated that prior to use, the nursing staff had noticed redness around the entry site on (b)(6),2023, and the patient had refused to attend the dialysis on (b)(6), 2023, because the patient's exit site was red and crusty.On (b)(6) 2023, a swab was taken from the entry site and it was positive for mrsa (methicillin-resistant staphylococcus aureus), but there was no specific treatment given for the entry site as the mrsa blood culture taken was negative, and the patient was systemically unwell.The patient was known to have nasal mrsa carriage and had just completed a course of hibiscrub showers and bactroban (three times a day in the nose).The nasal swab was still positive after the decolonization treatment.Flushing was done prior to use, and the flow was good enough to start the dialysis.There were no other defects/damages found on the product.There was no excessive force used on the device.Tego was not utilized, and there were no other products being utilized with the device.The standard cleaning of the dialysis catheter in-out unit was with green clinell device wipes with 2% chlorhexidine, 70% alcohol, and bd chloraprep on dressing change days.Heparin was the anticoagulant used.The catheter had been in place for 245 days.The product was replaced, and as a medical intervention/treatment due to the event, the patient had a new line placed on (b)(6), 2023 into the left subclavian with new tunnel made, and the standard decolonization (hibiscrub and bactroban) protocol was used again.The treatment was able to continue and was completed after the insertion of the new line.The patient was admitted to the hospital on the day of the event, but only for a few hours as the patient refused the new line and had refused post-treatment line removal and the patient returned to the hospital on (b)(6), 2023 as a day case for a new line.There was a blood loss of 300 milliliters (ml) since one circuit was unable to washback.A blood transfusion was not required due to the event.

• 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: 18564050
• MDR Text Key: 333496581
• Report Number: 3009211636-2024-00039
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013179
• UDI-Public: 10884521013179
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111372
• 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
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 2203200106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Date Device Manufactured: 07/20/2022
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 97 KG