FDA Adverse Event
Summary report: N
CARDINAL HEALTH/ALARIS PRODUCTS
MDR report key: 835173
·
Received April 4, 2007
Report
- Report Number
- MW1042486
- Date Received
- April 4, 2007
- Date of Event
- March 13, 2007
- Report Date
- March 22, 2007
- Manufacturer
- *
- Product Code
- MEA
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE FOLLOWING INFORMATION WAS OBTAINED FROM THE DEVICE'S EVENT LOG: A SYRINGE WITH FENTANYL 2500MCG/ML WAS INSTALLED TO AN ALARIS PUMP IN 2007 @ 1420. THE PRE-DETERMINED FLOW RATE WAS SET AT 150ML/HR. THE ENTIRE SYRINGE (50ML) WAS INFUSED TO THE PATIENT WITHIN 22 MINUTES, THEREBY DELIVERING A DOSE OF 2500 MCG OF FENTANYL. THE NURSE BYPASSED THE GUARDRAIL WARNINGS 3 TIMES AND SHE PRESSED "CONFIRM" WHEN "ALERTED" THE VOLUME IN THE SYRINGE IS INADEQUATE TO DELIVER THE PROGRAMMED DOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDINAL HEALTH/ALARIS PRODUCTS | PATIENT CONTROLLED ANALGESIA (PCA) MODULE | MEA | * | PCA - 8120 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |