FDA Adverse Event
Injury
Summary report: N
CAREFUSION
MDR report key: 3890191
·
Received May 21, 2014
Report
- Report Number
- 3890191
- Event Type
- Injury
- Date Received
- May 21, 2014
- Date of Event
- March 17, 2014
- Report Date
- May 14, 2014
- Manufacturer
- CAREFUSION
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT RETURNED TO CVCCU APPROXIMATELY 1500, INSULIN DRIP INITIATED FOR BLOOD GLUCOSE OF 126 AT 2ML/HR(2 UNITS/HR) ON IV PUMP. APPROXIMATELY 10 MINUTES LATER, NOTICED INSULIN DRIP BAG WAS EMPTY/DRY. STOPPED IV PUMP, CLAMPED DRIP TUBING, AND CHECKED PT'S BLOOD SUGAR. PUMP VOLUME INFUSED DISPLAYED CORRECTLY AT 0.4ML. PT REQUIRED BLOOD GLUCOSE MONITORING EVERY 15 MINUTES AND LATER CHANGED TO EVERY 30 MINUTES. NO ADVERSE CONDITIONS WERE REACHED. IV PUMP IN QUESTION WAS IMMEDIATELY REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303605 | CAREFUSION | ALARIS IV PUMP MODULE | FRN | CAREFUSION | 8100, 8015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |