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

Model Number DIALYSIS UNKNOWN

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

Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Title: plasma exchange in refractory acute disseminated encephalomyelitis associated with covid-19: technical challenges in a developing country source: © 2021.Thieme.All rights reserved.Georg thieme verlag kg, rüdigerstrasse 14, 70469 stuttgart, germany doi https://doi.Org/ 10.1055/s-0041-1722927.Issn 1304-2580.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, a pediatric patient with covid-19 (coronavirus disease 2019), sudden-onset asymmetric quadriparesis, painful loss of vision, and acute demyelinating encephalomyelitis (adem) that required plasma exchange (pex).After tolerating four alternate-day pex sessions well using 11.5-fr double lumen temporary hemodialysis catheter (covidien) inserted in right internal jugular vein and a competitor hemodialysis machine, the patient experienced fever with chills and was started on iv (intravenous) ceftazidime and vancomycin.The catheter was removed and the catheter tip later revealed (b)(6) on culture.The patient became afebrile in 2 days and was discharged from the hospital on day 29.

• 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
• 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: 14116662
• MDR Text Key: 289884593
• Report Number: 3009211636-2022-00092
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2022

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: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/15/2022
• 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): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female