MAUDE Adverse Event Report: FOLLETT LLC FOLLETT MEDICATION REFRIGERATOR ; REFRIGERATOR, FREEZER, BLOOD STORAGE

Model Number REF 20/25

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Multiple medication refrigerators from follett (manufacturer) were identified as having mold growth inside on bins and racks.Cleaning and disinfection removed the visible mold, but a week later small amounts of growth have returned.One refrigerator was sequestered and disassembled down to the evaporator where the same growth was visually identified.An unusual mold growth has been identified in several follett medication refrigerators.The pharmacy, infection prevention, biomedical engineering, safety, facilities have been working closely in collaboration with the follett refrigerator manufacturer over the past weeks to identify and correct those issues.We are also in consultation with our public health colleagues at the state level (who have reached out to cdc) who are in agreement with our approach pending any further recommendations.It's important to note that we have not seen any cases of fungal infection in our patients, related to this issue.Our short term plan is to inspect and clean any affected refrigerators.Our long term plan is to replace the module that houses the condensation coil/evaporator unit in affected refrigerators as we do not have a way of assuring a through and complete cleaning of those units.The remediation plan is complex and requires us to swap out the affected refrigerators, clean and disinfect medication bins and the units themselves.Eight refrigerators are confirmed for hyalodendron.Another 30+ culture swabs are pending.It is not known whether the fungus was introduced to the refrigerators at our facility, or at the time of manufacture.Serial numbers include: (b)(4).

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Type of Device: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Manufacturer (Section D): FOLLETT LLC; easton PA 18040
• MDR Report Key: 8281570
• MDR Text Key: 134495586
• Report Number: MW5083414
• Device Sequence Number: 7
• Product Code: KSE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2019
• 23 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF 20/25
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention