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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device flowmeter, blood, cardiovascular
Regulation Description Cardiovascular blood flowmeter.
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
DELTEX MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER ASSOCIATED SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERIMED AB
  SUBSTANTIALLY EQUIVALENT 1
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RFPI
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2019 3 3
2020 4 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Output Problem 3 3
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Device Alarm System 1 1
Crack 1 1
Disconnection 1 1
Leak/Splash 1 1
Failure to Power Up 1 1
Fitting Problem 1 1
Defective Device 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Aneurysm 1 1
No Consequences Or Impact To Patient 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II May-10-2016
2 Medistim Asa II Feb-26-2018
3 Vascular Technology, Inc. II Sep-12-2018
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