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 Death (1802)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Title clinical outcomes and risk factors for tunneled hemodialysis catheter-related bloodstream infections source open forum infectious diseases brief report, 2020 (1-4) date of acceptance: 3 april 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

This study aimed to investigate factors associated with catheter-related bloodstream infections (crbsi) in patients with a primary tunneled catheter for hemodialysis (tchd) inserted at a hospital and report their microbiological and clinical outcomes.Patients with primary insertion of a tchd were included.Patients were followed until the time of primary tchd removal (documented in hospital records), death with a functioning tchd (whichever came first).Insertions were performed by interventional radiologists using tunneled cuffed catheters.A total of 227 patients had a primary insertion of a tchd.Of the 227 patients, 157 (69%) patients had a tchd inserted for acute hd, and in 68 (30%) patients for maintenance renal replacement therapy (rrt) access failure, for example, malfunction or infection of either a peritoneal dialysis catheter or arterio-venous access.Tchd was removed in 45 (20%) patients who no longer required rrt, in 95 (42%) with established permanent rrt access, 15 (7%) patients died with a functioning tchd.There was a total of 39 crbsis in 227 primary tchd insertions (17%), requiring removal in 37 (16%) cases.The 2 were in-hospital deaths, 1 (2.6%) episode of methicillin-susceptible s.Aureus endocarditis, and 1 (2.6%) episode of candida endophthalmitis.The device did not cause nor contribute to the patient death.

• 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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10380056
• MDR Text Key: 202056318
• Report Number: 3009211636-2020-00179
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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: 07/09/2020
• 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): Other
• Patient Age: 60 YR