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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 5
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 16
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
Other (for use when an appropriate device code cannot be identified) 20
Device operates differently than expected 12
Pumping stopped 10
Fluid leak 10
No Information 7
Leak 6
Air leak 5
Break 4
Detachment of device component 4
Performance 4
Unknown (for use when the device problem is not known) 4
Device Issue 4
Suction issue 4
Inadequate filtration process 3
Infusion or flow issue 3
No Known Device Problem 3
Material integrity issue 2
No flow 2
Device inoperable 2
Vacuum, loss of 2
Device displays error message 2
Filter break(s) 2
Fracture 2
Clumping in device or device ingredient 2
Disconnection 2
Explode 1
Computer software issue 1
Crack 1
Decrease in suction 1
Foreign material 1
Failure to pump 1
Loose or intermittent connection 1
Incompatibility problem 1
Noise 1
Tube(s), defective 1
Component missing 1
Inappropriate shock 1
Tears, rips, holes in device, device material 1
Tubing, incorrect placement of 1
Not Applicable 1
Total Device Problems 136

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