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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
  1.  K043140  EXPRESS AND OASIS CHEST DRAIN
  2.  K883663  ATS BLOOD RECOVERY BAG
  3.  K893402  COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY
  4.  K897126  ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM
  5.  K897127  ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
  6.  K904794  IN-LINE ATS BLOOD RECOVERY BAG
  7.  K912609  MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
  8.  K912610  MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
  9.  K912956  ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
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
Fluid leak 11
Pumping stopped 10
No Information 7
Leak 6
Air leak 5
Break 4
Detachment of device component 4
Performance 4
Suction issue 4
Device Issue 4
Unknown (for use when the device problem is not known) 4
Inadequate filtration process 3
Infusion or flow issue 3
No Known Device Problem 3
Material integrity issue 2
No flow 2
Device displays error message 2
Filter break(s) 2
Device inoperable 2
Vacuum, loss of 2
Fracture 2
Clumping in device or device ingredient 2
Disconnection 2
Explode 1
Computer software issue 1
Crack 1
Decrease in suction 1
Hole in material 1
Foreign material 1
Failure to pump 1
Loose or intermittent connection 1
Noise 1
Inappropriate shock 1
Tears, rips, holes in device, device material 1
Tubing, incorrect placement of 1
Incompatibility problem 1
Tube(s), defective 1
Component missing 1
Not Applicable 1
Total Device Problems 138

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