MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Title: prolonged intermittent renal replacement therapy for acute kidney injury in covid-19 patients with acute respiratory distress syndrome source: blood purification 2021;50:355¿363.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature case study, this was a single-center, prospective, observational study performed at a tertiary reference hospital designated to treat exclusively patients with covid-19 from march 16, 2020 to june24, 2020.The study identified 224 covid-19 patients admitted to the icu; 136 (60.7%) of them developed hospital-acquired aki (acute kidney injury), and among them, 39 (29%) had stage 3 aki according to kdigo (kidney disease improving global outcomes) definitions.In these patients, 21 (15%) initiated prolonged intermittent renal replacement therapy (pirrt).Intradialytic hypotensive events occurred in 56 (43%) procedures.Intradialytic hypotensive episodes were identified promptly in the majority of episodes and treated with 2 maneuvers: increasing norepinephrine dose (54/56, 96%) and reducing fluid removal rate by decreasing total ultrafiltrate (10/56, 18%) or by increasing session duration (46/56, 82%).Fifteen (12%) pirrt treatments were discontinued before reaching the ultrafiltration goal due to severe intradialytic hypotension.Other causes of pirrt discontinuation were recurrent dialysis system clotting, arrhythmia, and refractory hypoxemia in 5, 1, and 1 procedure, respectively.Two patients were switched to crrt due to severe hypotension after 2 consecutive pirrt treatments failed on subsequent days.During follow-up, 11 patients (52%) recovered from aki and respiratory failure, and 1 (5%) patient was still hospitalized at the time of writing this report, yet the patient has recovered renal function and, subsequently, pirrt has already been discontinued.

Manufacturer Narrative

Additional information: removal of fdp and imf code of hospitalization or prolonged hospitalization and outcome attributed to adverse event 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: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12462853
• MDR Text Key: 271261403
• Report Number: 3009211636-2021-00249
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention