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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
  1.  K872927  DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
  2.  K892819  AUTOTRANSFUSION DEVICE
  3.  K901232  IMPRAFLO AUTOTRANSFUSION DEVICE
  4.  K901401  DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
  5.  K904515  IMPRAFLO 3500 SERIES
  6.  K913684  DAVOL POST-OP AUTOTRANSFUSION SYSTEM
  7.  K914119  DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
  8.  K925827  IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
  9.  K931552  DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
  10.  K931899  DAVOL ATS
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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