FDA.reportPublic FDA data

MAUDE MDR 8569468

MDR report key
8569468
Report number
2150060-2019-00034
Event key
0
Event type
3
Date of event
2019-04-04
Date received
2019-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAUREN JOHNSON
Address
14605 28TH AVE N PLYMOUTH MN 55447 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANTAGE PLUSAUTOMATED ENDOSCOPE REPROCESSORMEDIVATORSFEB1-2-510.003R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-0101. O

Event Narratives#

N

Patient 1

THE FACILITY REPORTED EMPLOYEES DEVELOPED EXPOSURE SYMPTOMS FROM RAPICIDE PA HIGH LEVEL DISINFECTANT (HLD) THAT LEAKED FROM THEIR ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE FACILITY REPORTED THE AER HAD A LEAK THEY COULD NOT LOCATE. THEY REPORTED HLD RAN ONTO THE FLOOR, THEN CLEANED UP WITH TOWELS WHICH WERE THE PLACED IN THE DIRTY LAUNDRY HAMPER. AFTER A COUPLE HOURS, THE EMPLOYEES REPORTED A STRONG ODOR AND NOTICED A HAZE IN THE ROOM. ONE OF THE EMPLOYEES OPENED THE HAMPER TO FIND A THIN CLOUD OF FUMES AND REPORTED THE TOWELS HAD SOME TYPE OF NOTICEABLE CHEMICAL BREAKDOWN. THE FACILITY USED BAKING SODA TO NEUTRALIZE THE TOWELS AND CHEMICAL. THREE EMPLOYEES REPORTED SYMPTOMS OF EYE AND THROAT IRRITATION, NAUSEA, HEADACHE AND CHEST PAIN. THE EMPLOYEES WERE SENT TO EMPLOYEE HEALTH AND REFERRED TO ED FOR EVALUATION. THEY ARE REPORTED TO BE FINE. MEDIVATORS FIELD SERVICE ENGINEER ARRIVED ON SITE AND REPAIRED THE LEAK. THE MACHINE WAS TESTED, AND IT RAN WITHIN SPECIFICATION. THE FACILITY FAILED TO FOLLOW THE IFU AND SDS DISPOSAL INSTRUCTIONS FOR RAPICIDE PA HLD. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT SYSTEM.

D

Patient 1

THE FACILITY REPORTED EMPLOYEES DEVELOPED EXPOSURE SYMPTOMS FROM RAPICIDE PA HIGH LEVEL DISINFECTANT THAT LEAKED FROM THEIR ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR (AER).