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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, bacterial, breathing-circuit
Product CodeCAH
Regulation Number 868.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
DRÄGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GREAT GROUP MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MD DIAGNOSTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUAKUN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PASSY-MUIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHARMA SYSTEM AB
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 32 32
2021 56 56
2022 67 67
2023 40 40
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 31 31
Gas/Air Leak 22 22
Material Split, Cut or Torn 16 16
Crack 15 15
Material Separation 13 13
Leak/Splash 12 12
Break 12 12
Detachment of Device or Device Component 12 12
Filtration Problem 11 11
Pressure Problem 10 10
Mechanical Problem 10 10
Disconnection 10 10
Use of Device Problem 10 10
Complete Blockage 7 7
Device Markings/Labelling Problem 7 7
Device Damaged Prior to Use 6 6
Contamination 4 4
Output Problem 4 4
Insufficient Information 4 4
Moisture or Humidity Problem 3 3
No Flow 3 3
Improper Flow or Infusion 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Defective Component 3 3
Component Missing 3 3
Particulates 3 3
Device Alarm System 3 3
Partial Blockage 3 3
Loose or Intermittent Connection 3 3
Excess Flow or Over-Infusion 2 2
Fluid/Blood Leak 2 2
Fracture 2 2
Material Fragmentation 2 2
Gas Output Problem 2 2
Defective Device 2 2
Failure to Deliver 2 2
Infusion or Flow Problem 2 2
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sharp Edges 1 1
Air/Gas in Device 1 1
Temperature Problem 1 1
Packaging Problem 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Slipped 1 1
Tidal Volume Fluctuations 1 1
Structural Problem 1 1
Decreased Sensitivity 1 1
Failure to Run on Battery 1 1
Decrease in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequate Filtration Process 1 1
Device Contamination with Body Fluid 1 1
Imprecision 1 1
Collapse 1 1
Difficult to Insert 1 1
Material Disintegration 1 1
Misassembled 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 103 103
Low Oxygen Saturation 35 35
No Consequences Or Impact To Patient 31 31
Insufficient Information 23 23
No Patient Involvement 10 10
No Known Impact Or Consequence To Patient 7 7
Bradycardia 5 5
Respiratory Distress 4 4
Cardiac Arrest 3 3
Hypoventilation 3 3
Hypoxia 3 3
Cyanosis 3 3
Diminished Pulse Pressure 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cough 3 3
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Ventilator Dependent 2 2
Respiratory Failure 2 2
No Code Available 2 2
Patient Problem/Medical Problem 1 1
Bronchospasm 1 1
Dyspnea 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Capsular Contracture 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Pulmonary Edema 1 1
Cardiopulmonary Arrest 1 1
Electrolyte Imbalance 1 1
Distress 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alliance Tech Medical, Inc II Dec-19-2019
2 Covidien, LP II Jun-16-2021
3 Draeger Medical, Inc. I Jun-10-2022
4 S & MOHR AMERICA, S.A. DE C.V. III Feb-22-2023
5 Smiths Medical ASD Inc. II Aug-28-2023
6 TELEFLEX LLC I Oct-14-2022
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