Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device monitor, blood-gas, on-line, cardiopulmonary bypass
Product CodeDRY
Regulation Number 870.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 63 63
2020 35 35
2021 42 42
2022 37 37
2023 41 41
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 128 128
Leak/Splash 67 67
Electrical /Electronic Property Problem 5 5
Smoking 5 5
Failure to Power Up 5 5
Thermal Decomposition of Device 5 5
Insufficient Information 3 3
Pumping Stopped 3 3
Unable to Obtain Readings 3 3
Incorrect Measurement 3 3
Electrical Overstress 2 2
Failure to Sense 2 2
Under-Sensing 1 1
Failure to Calibrate 1 1
Computer Software Problem 1 1
Incorrect Interpretation of Signal 1 1
Gel Leak 1 1
Complete Loss of Power 1 1
Overheating of Device 1 1
High pH 1 1
Inappropriate or Unexpected Reset 1 1
Display or Visual Feedback Problem 1 1
Fluid/Blood Leak 1 1
Sparking 1 1
Disconnection 1 1
False Negative Result 1 1
Electrical Power Problem 1 1
Crack 1 1
Image Display Error/Artifact 1 1
Failure to Recalibrate 1 1
Use of Incorrect Control/Treatment Settings 1 1
Calibration Problem 1 1
Degraded 1 1
Gas/Air Leak 1 1
Decrease in Pressure 1 1
Electrical Shorting 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
No Consequences Or Impact To Patient 58 58
No Patient Involvement 32 32
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 6 6
Blood Loss 5 5
No Information 4 4
Air Embolism 2 2
Death 1 1
Ischemia 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
-
-