FDA Adverse Event
Summary report: N
SIGMA SPECTRUM
MDR report key: 1920576
·
Received November 22, 2010
Report
- Report Number
- 1920576
- Date Received
- November 22, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 22, 2010
- Manufacturer
- SIGMA INTERNATIONAL
- Product Code
- FRN
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
COMPLAINT FROM NURSING THE IV PUMP OVER INFUSED. PUMP STATED THAT 7.2 ML HAS BEEN INFUSED BUT THE 100 ML BAG WAS ALMOST EMPTY. CLINICAL ENGINEERING CHECK PUMP FOR OPERATION. PUMP WAS SET TO DELIVER 2.4 ML/HR. WHEN CHECKED OUT PUMP WAS DELIVERING 24 ML/HR AT THE 2.4 ML/HR RATE. IV TUBING WAS RE-SEATED INTO THE PUMP AT A DIFFERENT LOCATION ON THE TUBING. PUMP THEN DELIVERED THE CORRECT DOSE OF 2.4 ML/HR AND COULD NOT DUPLICATE THE ERROR FROM THAT POINT ON. NO MISLOAD OF THE TUBING WAS OBSERVED AT TIME OF RE-LOADING THE IV TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA SPECTRUM | IV PUMP | FRN | SIGMA INTERNATIONAL | SPECTRUM | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |