[27848836]
Picis clinical solutions received an enhancement request on (b)(6) 2015: "a sentenial event occurred related to patient weight in lbs being entered in the kg box on triage. I am requesting that weight entry be an option on the sites page allowing the administrator to select weight entry in kg only" the patient weight was documented incorrectly in the ed pulsecheck application by a clinician triaging the patient. The triage nurse obtained a value for the patient's weight measured in lbs and incorrectly documented it into the ed pulsecheck field labeled kg. This resulted in a documented weight more than twice the patient's actual weight. Patient weight was documented as 53. 8 kg when actual weight was (b)(6) kg. It was further identified that a weight based medication (phenobarbitol) dose was administered to the patient based on the incorrect weight value entered. The dose was calculated by the ordering provider based upon weight recorded within ed pulsecheck. The weight based medication administered to patient may have caused the need for the patient to be transferred to another facility for further treatment. There was no confirmation from the receiving hospital provider that the medication administered was the cause or contributing factor to the patient's condition. The ed pulsecheck product currently has two template fields for the documentation of a patient's weight, a field to document in pounds and a field to document weight in kilograms. The clinician must document in the field that corresponds to the units in which the weight was measured. The condition reported was related to a clinician documenting inaccurate information into a clearly labeled template field within ed pulsecheck. The documented weight did not trigger an out of normal weight notification because the weight entered was within normal weight parameters based on age/weight threshold parameters configured in ed pulsecheck by hospital team. Picis clinical solutions is planning to release the next version of the ed pulsecheck product by the end of (b)(6) 2015. This version of ed pulsecheck (v5. 6) will include an enhancement to only have the kg field shown for weight data entry. This enhancement may minimize the risk of a data entry error, although the enhancement does not prevent the risk of data entry error. The ed pulsecheck product did not cause or contribute to an adverse event and did not malfunction. The ed pulsecheck product operated as intended, however based upon the fda's mdr guidance related to user error, picis clinical solutions is submitting this medical device report to the fda.
Patient Sequence No: 1, Text Type: D, B5