MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN; SYSTEM, THERMAL REGULATING

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

During an inventory of all equipment with storage tanks, it was discovered that the arctic sun water units (2 units), were found to be contaminated with water borne pathogens and the water in the tank was cloudy with black specks.The machines were found to have significant gram negatives.The ifu on the devices were being followed with use of the recommended disinfectant chloramine.The biomed department was made aware and ran disinfection cycles on the machines.Concern was raised that the disinfection protocol of every 6 months per manufacturer is inadequate.Per our infection control professionals, there was epidemiological association with arctic sun machines for findings of burkholderiain tracheal aspirate present in 2 patients who had used the machines.A meeting was conducted to discuss the findings with manufacturer rep, plan is now in place to clean the machines monthly and to only disconnect outside of patients' room to minimize exposure to any contaminant.

• Brand Name: ARCTIC SUN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 14653223
• MDR Text Key: 293703832
• Report Number: 14653223
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Weight: 116 KG