MalfunctionKZB
UNIFUSOR
Received Sep 16, 2010 · Event occurred Aug 1, 2010
Report 2244861-2010-00001 · MDR key 1841305
Device
Generic name
Pressure Infusor For An Iv Bag
Manufacturer
Cas Medical Systems, Inc. (statcorp)Model number
803FGACatalog number
803FGA
Lot number
UNK
Product problems
- Occlusion Within Device
- Decrease in Pressure
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
"THE INFORMATION PASSED ON FROM THE DISTRIBUTOR INDICATES THAT THE DEVICE USED IN THE HOSPITAL DID NOT MAINTAIN ITS DESIRED INFLATION PRESSURE FOR THE EXPECTED TIME OF USE. GRADUALLY DECREASING INFLATION PRESSURE LED TO THE OCCLUSION OF A PATIENT'S ARTERIAL LINE AND RESULTED IN THE NEED TO REPLACE THE ARTERIAL LINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE PRODUCTS GAUGE T-FITTING WAS IDENTIFIED BY VISUAL EXAMINATION AS THE SOURCE OF THE LEAK.
Remedial action
- Replace