CERNER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for CERNER manufactured by Cerner Corporation.

Event Text Entries

[60349233] Pt was discharged from our children's hospital with a prescription for acetaminophen 60 mg. The product selected was 160mg/5ml and showed a dose of 60mg or 1. 88 ml which is what the pt was receiving in house. We use (b)(4) at our facility. The discharge medication reconciliation was done through (b)(4) as is our process, but the dose of the drug does not transmit to the pt summary that is provided to the pt. Only the product and frequency transmit. The dose does transmit to any prescriptions but since this was an over the counter medication, the parents were using the pt summary to know what to give their child. It appeared on the pt summary that the pt should receive acetaminophen 160mg/5ml as their dose. The parents gave the pt this much higher dose of acetaminophen after discharge and the pt was then readmitted to the emergency department with signs and symptoms of tylenol toxicity and received acetylcysteine for treatment of overdose. This error was presented at our facility safety operations council and our info systems department escalated this concern to (b)(4) to address since this potentially impacts all users of (b)(4) who prescribe over the counter products upon discharge. We have not received a response from them regarding a resolution for this issue. (b)(4). Severity: error resulted in treatment or intervention; temporary pt harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066086
MDR Report Key6108901
Date Received2016-11-15
Date of Report2016-08-25
Date Added to Maude2016-11-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCERNER
Generic NameCERNER SOFTWARE
Product CodeMMH
Date Received2016-11-15
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCERNER CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.