MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-03 for CERNER MILLENNIUM INPATIENT PHARMACY, POWERORDERS, AND POWERPLANS 2012.01 - 2018.01 N/A manufactured by Cerner Corporation.
[113426639]
Cerner distributed a flash notification on june 29, 2018 to all potentially impacted client sites. The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[113426640]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium inpatient pharmacy, powerorders? , and powerplans? , nor are these products currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's millennium inpatient pharmacy, powerorders, and powerplans dosage calculator. The issue involves cerner millennium inpatient pharmacy, powerorders, and powerplans and affects users that utilize dosage calculator to calculate medication dosage. When a user clicks "apply" multiple times in dosage calculator, the system uses an incorrect date of birth to calculate estimated values for creatinine clearance (crcl), ideal body weight (ibw), and body surface area (bsa), which produces incorrect values. When these incorrect values are used to calculate medication doses, the system calculates an incorrect dose. This issue could result in a patient receiving the incorrect dosage of medication. Cerner has received communication that this issue may have contributed to an adverse patient event that led to a patient receiving an incorrect dose of carboplatin. The outcome of this event was not communicated to cerner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2018-00010 |
| MDR Report Key | 7661670 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-03 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2015-06-05 |
| Date Added to Maude | 2018-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCK CREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER MILLENNIUM INPATIENT PHARMACY, POWERORDERS, AND POWERPLANS |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2018-07-03 |
| Model Number | 2012.01 - 2018.01 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCK CREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-03 |