FDA.reportPublic FDA data

MAUDE MDR 565185

MDR report key
565185
Report number
565185
Event key
0
Event type
3
Date of event
2004-12-09
Date received
2004-12-20
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSMO 23GREVERSE OSMOSIS PURFICATION MACHINEGE OSMONICSJRS23G-HR(PA)4500**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-12-200

Event Narratives#

D

Patient 1

WATER WAS BEING PRODUCED BY THE RO, REVERSE OSMOSIS, SYSTEM, BUT WAS NOT ABLE TO REACH THE STORAGE TANK AND OUT TO THE LOOP. THE WATER LEVEL IN THE STORAGE TANK DROPPED TO 70 GALLONS, WHICH PUT THE SYSTEM INTO AN AUTOMATIC SHUT OFF MODE. IN AN EFFORT TO CONSERVE ON WATER THAT WAS NOT BEING PRODUCED BY THE RO SYSTEM, THE DIALYSATE FLOW ON ALL MACHINES WAS TURNED DOWN BY THE STAFF FROM 800 CC/MIN TO 500CC/MIN. THIS WOULD AFFECT THE AMOUNT OF UREA CLEARANCE DURING THE PATIENT'S NORMAL TREATMENT.THE PROBLEM TURNED OUT TO BE 2 VALVES WHICH WERE REPLACED. THIS PROBLEM HAS OCCURRED ONE OTHER TIME IN THE PAST.FURTHER FOLLOW UP REVEALED THAT THE STAFF WERE ALERTED OF THE PROBLEM BY THE SAFETY ALARM ON THE RO SYSTEM. THE OUTSIDE COMPANY THAT MAINTAINS THE SYSTEM CHANGED THE VALVES AND CHECKED THE WATER AFTER THE SYSTEM WAS REPAIRED. THE STAFF ALSO DOUBLE CHECKED THE WATER QUALITY TO MAKE SURE THAT THERE WERE NO PROBLEMS.