RX - WRITER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for RX - WRITER manufactured by Novus Rx, Llc.

Event Text Entries

[144947484] A (b)(6) pt received 4 doses of wrong sildenafil dose. Home dose is sildenafil 5 mg/ml, give 2 ml (10mg) every 8 hours. Upon completing medication reconciliation on admission, sildenafil ordered as 10 mg/ml solution, give 2 ml (20 mg) every 8 hours. The medication error was discovered when calling to refill outpatient prescription for sildenafil and verified formulation with outpatient pharmacy. Medication dose changed to sildenafil 10 mg/ml, give 1 ml (10 mg) every 8 hours after discovering medication error. Pt remained hemodynamically stable. Family notified of medication error. Event investigation: different concentrations, appears ordered in volume (2 ml) versus dose. Scm shows med ordered as mg using 10mg/ml, to give a volume of 2 ml. When provider did admission med rec, believe they must have entered into outpatient med review (omr) as 2 ml using the scm option of concentration of 10 mg/ml (rx writer issue/multum issue); pt takes 5 mg/ml concentration; p&t approved std is 2. 5mg/ml. Since pt's concentration was not available in rx writer, order was completed with the double concentration and difficult to tell what their home dose was when pharmacist verified. Unable to replicate in scm test because there is no option for 5mg/ml suspension; 10 mg/ml is the only option and forced provider to use this incorrect concentration. Issues: scm, rx writer, multiple concentrations of meds. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086542
MDR Report Key8600479
Date Received2019-05-10
Date of Report2019-05-10
Date Added to Maude2019-05-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRX - WRITER
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-05-10
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNOVUS RX, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-10

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