FDA Adverse Event
Summary report: N
MEDFUSION
MDR report key: 1053183
·
Received May 12, 2008
Report
- Report Number
- 1053183
- Date Received
- May 12, 2008
- Date of Event
- March 31, 2007
- Report Date
- May 2, 2008
- Manufacturer
- SMITHS MEDICAL
- Product Code
- FRN
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
POSSIBLE UNDER INFUSION OF MEDICATION TO PATIENT. THE PUMP WAS SET TO DELIVER IN THE "BODY WEIGHT" MODE INSTEAD OF VOLUME OVER TIME MODE, AND ML/HR MODE. THE RATE SET ON THE PUMP WAS DISPLAYED AS .080 MG/KG/MIN. THE PUMP WAS TESTED AT THE SETTING DISPLAYED. IT WAS SET TO A CONCENTRATION EQUAL TO 10 UG/ML, AND WEIGHT EQUAL TO 8.05 KG. THE CALCULATED RATE OF THIS CONCENTRATION MODE CAME TO 4.83 ML PER HOUR. THE BIOMED TESTS CONFIRM A DELIVERY OF 4.686 ML/HR THAT CALCULATES TO AN ERROR RATE OF 2.98%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDFUSION | PUMP, SYRINGE | FRN | SMITHS MEDICAL | 2010 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 MO |