{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-13"
  },
  "results": [
    {
      "term": "Fluid/Blood Leak",
      "count": 3441
    },
    {
      "term": "Break",
      "count": 699
    },
    {
      "term": "Crack",
      "count": 429
    },
    {
      "term": "Leak/Splash",
      "count": 280
    },
    {
      "term": "Adverse Event Without Identified Device or Use Problem",
      "count": 232
    },
    {
      "term": "Device Displays Incorrect Message",
      "count": 176
    },
    {
      "term": "Disconnection",
      "count": 172
    },
    {
      "term": "Alarm, audible",
      "count": 124
    },
    {
      "term": "Air/Gas in Device",
      "count": 123
    },
    {
      "term": "Detachment of Device or Device Component",
      "count": 91
    },
    {
      "term": "Device Contamination with Chemical or Other Material",
      "count": 88
    },
    {
      "term": "Insufficient Device Problem Information",
      "count": 81
    },
    {
      "term": "Improper or Incorrect Procedure or Method",
      "count": 79
    },
    {
      "term": "Device Alarm System",
      "count": 74
    },
    {
      "term": "Device Issue",
      "count": 59
    },
    {
      "term": "Connection Problem",
      "count": 58
    },
    {
      "term": "Obstruction of Flow",
      "count": 57
    },
    {
      "term": "Other (for use when an appropriate device code cannot be identified)",
      "count": 56
    },
    {
      "term": "Protective Measures Problem",
      "count": 51
    },
    {
      "term": "Inaccurate Flow Rate",
      "count": 48
    },
    {
      "term": "No Display/Image",
      "count": 46
    },
    {
      "term": "Replace",
      "count": 42
    },
    {
      "term": "Material Puncture/Hole",
      "count": 41
    },
    {
      "term": "Device Operates Differently Than Expected",
      "count": 38
    },
    {
      "term": "Material Split, Cut or Torn",
      "count": 35
    },
    {
      "term": "Material Rupture",
      "count": 34
    },
    {
      "term": "Loose or Intermittent Connection",
      "count": 33
    },
    {
      "term": "Air Leak",
      "count": 32
    },
    {
      "term": "Display or Visual Feedback Problem",
      "count": 31
    },
    {
      "term": "Coagulation in Device or Device Ingredient",
      "count": 30
    },
    {
      "term": "Repair",
      "count": 27
    },
    {
      "term": "Use of Device Problem",
      "count": 27
    },
    {
      "term": "Loss of Power",
      "count": 26
    },
    {
      "term": "Blank screen",
      "count": 21
    },
    {
      "term": "Pumping Stopped",
      "count": 21
    },
    {
      "term": "Unknown (for use when the device problem is not known)",
      "count": 20
    },
    {
      "term": "Malfunction",
      "count": 19
    },
    {
      "term": "Misassembled",
      "count": 19
    },
    {
      "term": "Output, high",
      "count": 18
    },
    {
      "term": "Computer Software Problem",
      "count": 16
    },
    {
      "term": "Complete Blockage",
      "count": 15
    },
    {
      "term": "Self-Activation or Keying",
      "count": 15
    },
    {
      "term": "Failure to Disconnect",
      "count": 14
    },
    {
      "term": "Improper Flow or Infusion",
      "count": 14
    },
    {
      "term": "Increased Pump Speed",
      "count": 14
    },
    {
      "term": "No Audible Alarm",
      "count": 14
    },
    {
      "term": "Fracture",
      "count": 13
    },
    {
      "term": "Increase in Pressure",
      "count": 13
    },
    {
      "term": "Output, low",
      "count": 13
    },
    {
      "term": "Nonstandard Device",
      "count": 12
    },
    {
      "term": "Defective Component",
      "count": 11
    },
    {
      "term": "Excess Flow or Over-Infusion",
      "count": 10
    },
    {
      "term": "Failure to Power Up",
      "count": 10
    },
    {
      "term": "Filtration Problem",
      "count": 10
    },
    {
      "term": "Hole In Material",
      "count": 10
    },
    {
      "term": "Calibration Error",
      "count": 9
    },
    {
      "term": "Device Inoperable",
      "count": 9
    },
    {
      "term": "Inaccurate Information",
      "count": 9
    },
    {
      "term": "Material Integrity Problem",
      "count": 9
    },
    {
      "term": "Material Perforation",
      "count": 9
    },
    {
      "term": "Noise",
      "count": 9
    },
    {
      "term": "Therapeutic or Diagnostic Output Failure",
      "count": 9
    },
    {
      "term": "Vibration",
      "count": 9
    },
    {
      "term": "Failure to Pump",
      "count": 8
    },
    {
      "term": "Filling Problem",
      "count": 8
    },
    {
      "term": "Infusion or Flow Problem",
      "count": 8
    },
    {
      "term": "Alarm, failure of warning",
      "count": 7
    },
    {
      "term": "Application Interface Becomes Non-Functional Or Program Exits Abnormally",
      "count": 7
    },
    {
      "term": "Computer failure",
      "count": 7
    },
    {
      "term": "Computer hardware error",
      "count": 7
    },
    {
      "term": "Defective Device",
      "count": 7
    },
    {
      "term": "Failure to Infuse",
      "count": 7
    },
    {
      "term": "Gas/Air Leak",
      "count": 7
    },
    {
      "term": "No Flow",
      "count": 7
    },
    {
      "term": "Off-Label Use",
      "count": 7
    },
    {
      "term": "Unstable",
      "count": 7
    },
    {
      "term": "Appropriate Device Problem Term/Code Not Available",
      "count": 6
    },
    {
      "term": "Bubble(s)",
      "count": 6
    },
    {
      "term": "Device Misassembled During Manufacturing /Shipping",
      "count": 6
    },
    {
      "term": "Failure to Prime",
      "count": 6
    },
    {
      "term": "No Apparent Adverse Event",
      "count": 6
    },
    {
      "term": "Partial Blockage",
      "count": 6
    },
    {
      "term": "Component Misassembled",
      "count": 5
    },
    {
      "term": "Detachment Of Device Component",
      "count": 5
    },
    {
      "term": "Failure of Device to Self-Test",
      "count": 5
    },
    {
      "term": "Failure to Deliver",
      "count": 5
    },
    {
      "term": "False Device Output",
      "count": 5
    },
    {
      "term": "Material Separation",
      "count": 5
    },
    {
      "term": "Material Twisted/Bent",
      "count": 5
    },
    {
      "term": "Mechanical Problem",
      "count": 5
    },
    {
      "term": "Overdelivery",
      "count": 5
    },
    {
      "term": "Smoking",
      "count": 5
    },
    {
      "term": "Activation Problem",
      "count": 4
    },
    {
      "term": "Backflow",
      "count": 4
    },
    {
      "term": "Component Missing",
      "count": 4
    },
    {
      "term": "Defective Alarm",
      "count": 4
    },
    {
      "term": "Device Dislodged or Dislocated",
      "count": 4
    },
    {
      "term": "Device Handling Problem",
      "count": 4
    },
    {
      "term": "Erratic or Intermittent Display",
      "count": 4
    },
    {
      "term": "Error or warning message, failure to produce",
      "count": 4
    }
  ]
}