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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, autotransfusion
Regulation Description Autotransfusion apparatus.
Product CodeCAC
Regulation Number 868.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 12
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 10
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 7
CONMED
  SUBSTANTIALLY EQUIVALENT 3
CYTORI THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIDECO
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 6
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 17
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 11
SORIN
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Infusion or flow issue 26
Other (for use when an appropriate device code cannot be identified) 20
Fluid leak 13
Device operates differently than expected 13
Leak 12
Pumping stopped 10
Break 8
Suction issue 7
No Information 7
Air leak 5
Detachment of device component 4
Disconnection 4
Performance 4
Unknown (for use when the device problem is not known) 4
Inadequate filtration process 4
Device Issue 4
No Known Device Problem 3
Disassembly 3
Crack 2
Decrease in suction 2
Clumping in device or device ingredient 2
Fracture 2
Filter break(s) 2
Device inoperable 2
Vacuum, loss of 2
Material integrity issue 2
No flow 2
Device displays error message 2
Manufacturing or shipping issue associated with device 1
Difficult to open or close 1
Failure to shut off 1
Incompatibility problem 1
Not Applicable 1
Improper or incorrect procedure or method 1
Noise 1
Inappropriate shock 1
Tears, rips, holes in device, device material 1
Tubing, incorrect placement of 1
Failure to pump 1
Tube(s), defective 1
Component missing 1
Hole in material 1
Loose or intermittent connection 1
Explode 1
Foreign material 1
Computer software issue 1
Total Device Problems 189

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