FOLLETT MEDICATION REFRIGERATOR REF 20/25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for FOLLETT MEDICATION REFRIGERATOR REF 20/25 manufactured by Follett Llc.

Event Text Entries

[134495586] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5083414
• MDR Report Key: 8281570
• Date Received: 2019-01-25
• Date of Report: 2019-01-15
• Date of Event: 2018-12-12
• Date Added to Maude: 2019-01-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 2

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 3

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 4

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 5

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 6

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 7

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 8

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 9

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 10

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 11

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 11
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 12

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 12
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 13

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 13
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 14

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 14
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Device Sequence Number: 15

• Brand Name: FOLLETT MEDICATION REFRIGERATOR
• Generic Name: REFRIGERATOR, FREEZER, BLOOD STORAGE
• Product Code: KSE
• Date Received: 2019-01-25
• Model Number: REF 20/25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 15
• Device Event Key: 0
• Manufacturer: FOLLETT LLC
• Manufacturer Address: EASTON PA 18040 US 18040

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-01-25