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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
Product CodeDPW
Regulation Number 870.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
FLOSONICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
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
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 4 4
2021 6 6
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 4 4
Difficult to Open or Close 3 3
Break 2 2
Insufficient Information 1 1
Disconnection 1 1
Device Alarm System 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 4 4
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 Corporation II Jul-20-2023
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