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 NumberMW5083414
MDR Report Key8281570
Date Received2019-01-25
Date of Report2019-01-15
Date of Event2018-12-12
Date Added to Maude2019-01-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 2

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 3

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 4

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 5

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No5
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 6

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No6
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 7

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No7
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 8

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No8
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 9

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No9
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 10

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No10
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 11

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No11
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 12

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No12
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 13

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No13
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 14

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No14
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040

Device Sequence Number: 15

Brand NameFOLLETT MEDICATION REFRIGERATOR
Generic NameREFRIGERATOR, FREEZER, BLOOD STORAGE
Product CodeKSE
Date Received2019-01-25
Model NumberREF 20/25
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No15
Device Event Key0
ManufacturerFOLLETT LLC
Manufacturer AddressEASTON PA 18040 US 18040


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-01-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.