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 12/04/2021

Event Type  Injury  

Manufacturer Narrative

Title: salvage of infected tunneled hemodialysis catheters using 70% ethanol lock solution: a brief report source: hemodialysis international.2021;1¿5.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, a patient presented with chronic kidney disease due to diabetic nephropathy that required hemodialysis therapy and had multiple access failures with the only available access was the right femoral vein.A 45 cm cuffed tunneled symmetric tip polyurethane catheter (palindrome dialysis catheter) was inserted, after 10 months of regular and uneventful use, the patient developed fever with chills during dialysis sessions, the blood cultures obtained from peripheral and catheter samples showed pseudomonas species, fever persisted despite parenteral cefaperazone-sulbactum, and gentamicin-heparin catheter lock (gentamicin 10 mg and heparin 1250 iu) in each lumen.Persistence of biofilm in the lumen was suspected, a 70% ethanol lock solution of 5 hours for six consecutive days followed by gentamicin-heparin lock performed, the patient remained afebrile and had no chills during or after the dialysis session.The repeat blood cultures, both peripheral and catheter samples done 28 days after alcohol lock were sterile.Hemodialysis was successfully continued through the same catheter.

• 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: 13527733
• MDR Text Key: 285602881
• Report Number: 3009211636-2022-00040
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: 01/28/2022
• 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: 65 YR
• Patient Sex: Female