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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 193
Leak 176
Break 102
Contamination during use 46
Fluid leak 39
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
Failure to reset 12
Incorrect or inadequate result 11
Source, leak(s) from 11
Inaccurate flowrate 11
Cut in material 11
Incorrect measurement 9
Particulates 7
Loose or intermittent connection 6
Tears, rips, holes in device, device material 6
Transducer failure 6
Unable to obtain readings 6
False device output 6
Hole in material 6
Defective item 6
High Readings 5
Device Issue 5
Wavelength, incorrect 5
Failure to flush 5
Incorrect display 5
Source, detachment from 5
Use of Device Issue 4
Sticking 4
False reading from device non-compliance 4
Bleed back 4
Other (for use when an appropriate device code cannot be identified) 4
Defective component 4
Tube(s), defective 4
Stopcock valve, failure of 4
Failure to zero 3
Blood pooling 3
Detachment of device or device component 3
Foreign material present in device 3
Blockage within device or device component 3
Foreign material 3
Unsealed device packaging 3
Kinked 3
Misassembled 3
Delivered as unsterile product 3
Occlusion within device 2
Pressure sensor failure 2
Difficult to remove 2
Electrical issue 2
Disassembly 2
Bubble(s) 2
Colony forming units 2
Connection issue 2
Device damaged prior to use 2
Obstruction within device 2
Tear, rip or hole in device packaging 2
Fitting problem 2
Tubing, incorrect placement of 2
Valve(s), defective 2
Air eliminator, defective 1
Cable, defective 1
Inadequate filtration process 1
Out-of-box failure 1
Device contamination with blood or blood product 1
Material perforation 1
Lens replacement 1
Blood in tubing 1
Malfunction 1
Solder joint failure 1
Overdelivery 1
Device operates differently than expected 1
Malposition of device 1
Low readings 1
Incorrect or inadequate test results 1
Improper flow or infusion 1
Infusion or flow issue 1
No Known Device Problem 1
Output issue 1
Pressure issue 1
Not Applicable 1
Compatibility 1
Connector pin failure 1
Decoupling 1
Design/structure problem 1
Burst 1
Abnormal 1
Biofilm coating in device 1
Material discolored 1
Dislodged 1
Erratic display 1
Fracture 1
Excess flow or overinfusion 1
Difficult to flush 1
Total Device Problems 1057

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 1
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 Sep-15-2016
3 ICU Medical, Inc. II Aug-07-2014
4 Utah Medical Products, Inc II Jun-13-2013

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