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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, blood-pressure, extravascular
Regulation Description Extravascular blood pressure transducer.
Product CodeDRS
Regulation Number 870.2850
Device Class 2


Premarket Reviews
ManufacturerDecision
A&E
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOSENSORS
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 7
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAMIC
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
REAVILLMED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 192
Leak 167
Break 102
Contamination during use 46
Fluid leak 38
Disconnection 36
Crack 33
Component(s), broken 31
Drift 30
Tube(s), buckling of 29
Air leak 23
Measurements, inaccurate 20
Material separation 18
Unknown (for use when the device problem is not known) 13
Source, leak(s) from 11
Inaccurate flowrate 11
Cut in material 11
Incorrect measurement 9
Failure to reset 9
Incorrect or inadequate result 7
Defective item 6
Loose or intermittent connection 6
Unable to obtain readings 6
False device output 6
Hole in material 6
Tears, rips, holes in device, device material 6
Transducer failure 6
High Readings 5
Particulates 5
Wavelength, incorrect 5
Source, detachment from 5
Incorrect display 5
Failure to flush 5
Other (for use when an appropriate device code cannot be identified) 4
Device Issue 4
Sticking 4
Stopcock valve, failure of 4
Use of Device Issue 4
Bleed back 4
False reading from device non-compliance 4
Defective component 4
Tube(s), defective 4
Foreign material 3
Misassembled 3
Delivered as unsterile product 3
Blockage within device or device component 3
Failure to zero 3
Unsealed device packaging 3
Detachment of device or device component 3
Blood pooling 3
Kinked 3
Device damaged prior to use 2
Tubing, incorrect placement of 2
Colony forming units 2
Fitting problem 2
Foreign material present in device 2
Occlusion within device 2
Pressure sensor failure 2
Electrical issue 2
Connection issue 2
Valve(s), defective 2
Obstruction within device 2
Disassembly 2
Difficult to remove 2
Bubble(s) 2
Decoupling 1
Material discolored 1
Device contamination with blood or blood product 1
Solder joint failure 1
Overdelivery 1
Tear, rip or hole in device packaging 1
Low readings 1
Failure to read input signal 1
Device operates differently than expected 1
Infusion or flow issue 1
Burst 1
Blood in tubing 1
Fracture 1
Migration of device or device component 1
Failure to prime 1
Difficult to flush 1
Abnormal 1
Compatibility 1
Connector pin failure 1
Device Difficult to Setup or Prepare 1
Tube(s), splitting of 1
Not Applicable 1
Air eliminator, defective 1
Cable, defective 1
No Known Device Problem 1
Biofilm coating in device 1
Increase in pressure 1
Pressure issue 1
Inadequate filtration process 1
Dislodged 1
Valve(s), failure of 1
Loose 1
Loss of power 1
Accuracy rate 1
Out-of-box failure 1
Total Device Problems 1034

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 2 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Sep-11-2013
2 ICU Medical, Inc. II Aug-07-2014
3 Utah Medical Products, Inc II Jun-13-2013

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