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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
A-M SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AG INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION GERMANY 234 GMBH
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EXCELERON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
GLENN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREAT GROUP MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MD DIAGNOSTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDISIZE BV
  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
PHARMA SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 1
QSERVE AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 98 98
2015 51 51
2016 34 34
2017 28 28
2018 33 33
2019 30 30
2020 32 32
2021 56 56
2022 67 67
2023 40 40
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 42 42
Obstruction of Flow 38 38
Material Separation 27 27
Crack 26 26
Device Operates Differently Than Expected 26 26
Gas/Air Leak 25 25
Break 23 23
Detachment of Device or Device Component 23 23
Tear, Rip or Hole in Device Packaging 19 19
Partial Blockage 19 19
Material Split, Cut or Torn 18 18
Material Discolored 16 16
Disconnection 13 13
Pressure Problem 13 13
Complete Blockage 13 13
Filtration Problem 12 12
Mechanical Problem 11 11
Use of Device Problem 11 11
Occlusion Within Device 11 11
Infusion or Flow Problem 10 10
Device Displays Incorrect Message 9 9
Device Contamination with Chemical or Other Material 9 9
Restricted Flow rate 8 8
Device Damaged Prior to Use 8 8
Moisture or Humidity Problem 8 8
Air Leak 8 8
Detachment Of Device Component 7 7
Device Markings/Labelling Problem 7 7
Improper Flow or Infusion 6 6
Fluid/Blood Leak 5 5
Device Inoperable 5 5
Failure to Infuse 5 5
Insufficient Information 5 5
Connection Problem 4 4
Component Missing 4 4
Moisture Damage 4 4
Contamination 4 4
Material Integrity Problem 4 4
Defective Device 4 4
Output Problem 4 4
Material Fragmentation 3 3
Fracture 3 3
Increase in Pressure 3 3
Contamination /Decontamination Problem 3 3
Failure to Deliver 3 3
Device Dislodged or Dislocated 3 3
Sticking 3 3
Particulates 3 3
No Flow 3 3
Appropriate Term/Code Not Available 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 104 104
No Patient Involvement 78 78
No Known Impact Or Consequence To Patient 77 77
Low Oxygen Saturation 44 44
Insufficient Information 27 27
No Information 16 16
Respiratory Distress 10 10
Bradycardia 10 10
Discomfort 6 6
Hypoxia 5 5
Respiratory Failure 4 4
No Code Available 4 4
Cardiac Arrest 4 4
Urinary Tract Infection 3 3
Unspecified Respiratory Problem 3 3
Cough 3 3
Diminished Pulse Pressure 3 3
Pulmonary Emphysema 3 3
Respiratory Arrest 3 3
Sepsis 3 3
Hypoventilation 3 3
Pneumothorax 3 3
Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cyanosis 3 3
Obstruction/Occlusion 2 2
Dyspnea 2 2
Cardiopulmonary Arrest 2 2
Bronchospasm 2 2
Extubate 2 2
Decreased Respiratory Rate 2 2
Airway Obstruction 2 2
Ventilator Dependent 2 2
Distress 2 2
Patient Problem/Medical Problem 2 2
Aspiration/Inhalation 1 1
Electrolyte Imbalance 1 1
Loss Of Pulse 1 1
Swollen Glands 1 1
Not Applicable 1 1
Increased Respiratory Rate 1 1
Pulmonary Edema 1 1
Capsular Contracture 1 1
High Blood Pressure/ Hypertension 1 1
Fainting 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A M Systems Inc II Jan-11-2012
2 Alliance Tech Medical, Inc II Dec-19-2019
3 Continental Medical Labs,Inc II Jun-03-2010
4 Covidien, LP II Jun-16-2021
5 Draeger Medical, Inc. I Jun-10-2022
6 King Systems Corp. dba Ambu, Inc. II Jan-05-2018
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 Pall Corporation II Jul-10-2014
9 S & MOHR AMERICA, S.A. DE C.V. III Feb-22-2023
10 Smiths Medical ASD Inc. II Aug-28-2023
11 TELEFLEX LLC I Oct-14-2022
12 Vital Signs Colorado Inc. II Jan-23-2014
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