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Infusion Pumps Safety Assurance

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Product codeDescription
FRNInfusion pump
MEAPatient controlled analgesia (PCA) infusion pump
MEBElastomeric infusion pump
LZGInsulin infusion pump
OPPInsulin bolus infusion pump
LZHEnteral infusion pump
MRZInfusion pump accessories
PHCInfusion Safety Management Software
Infusion Pump System HazardsSystem Hazard Definitions
Infusion Delivery ErrorIntended medication selected and delivery attempted, but failure to deliver within the right time, dose, volume, patient, or anatomical or physiologic site specifications. This can include over-delivery, under-delivery or delay in delivery situations.
Incorrect TherapyFailure to select or deliver the intended medication because the wrong substance was selected for delivery.
Biological/Chemical ContaminationUnintended contact with biological or chemical substance, or unintended patient or provider physiologic response to intended biological or chemical substance.
Traumatic InjuryBurns, cuts, abrasions, air embolisms, electric shock, etc.
  1. A description of the device design requirement being verified, including why it is essential to the proper functioning of the device;
  2. A description of the unit under test and how it relates to the final, finished device;
  3. The justification for the use of prototype or “production equivalent” devices or components during the design verification activity, if applicable;
  4. An explicit statement of the acceptance criteria for the verification activity;
  5. A detailed description of the verification method, including drawings and descriptions of the test apparatus where appropriate;
  6. An explanation of how the verification test set up simulates actual clinical use conditions, if applicable;
  7. The results of the verification activity;
  8. An analysis of the verification activity results; and 9. An explicit statement of any conclusions drawn from the verification activity.