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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, thermal, infusion fluid
Regulation Description Infusion pump.
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ARIZANT HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 2
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIEGLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELLTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEI INC., ADVANCED MEDICAL DIVISION
  SUBSTANTIALLY EQUIVALENT 1
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PALADIN BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RAND S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
THE SMITHWORKS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 18
Detachment of device component 10
Leak 6
No Known Device Problem 5
Pressure issue 5
Air leak 4
Use of Device Issue 3
Infusion or flow issue 3
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 2
Smoking 2
No Information 2
Foreign material 2
Fracture 2
Monitor display alarm, failure of 2
Poor quality image 1
Device emits odor 1
Unintended collision 1
Overheating of device or device component 1
Product quality issue 1
Melted 1
Burn of device or device component 1
Charred 1
Component(s), broken 1
Component falling 1
Component(s), overheating of 1
Contamination during use 1
Disconnection 1
Electrical issue 1
Not Applicable 1
Material deformation 1
No fail-safe mechanism 1
Improper or incorrect procedure or method 1
Wire(s), breakage of 1
Spark 1
Charging issue 1
Communication or transmission issue 1
Connection issue 1
Device operates differently than expected 1
Device unsafe to use in environment 1
Improper device output 1
Total Device Problems 95

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