FDA Adverse Event
Summary report: N
18" (46 CM) APPX 5.1 ML, EXT SET W/0. CLAMP
MDR report key: 11421371
·
Received March 5, 2021
Report
- Report Number
- 11421371
- Date Received
- March 5, 2021
- Date of Event
- December 5, 2020
- Report Date
- February 16, 2021
- Manufacturer
- ICU MEDICAL INC.
- Product Code
- FPA
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
WHEN PATIENT GOT UP TO USE RESTROOM NOTICED WET SPOT ON SHEET. IN ASSESSING IV TUBING, I DETERMINED DRIP WAS WELLING FROM CIRCLE NEAR TOP OF CHEMO FILTER ON THE CHEMO HYDRATION/MAINTENANCE INTRAVENOUS FLUID (MIVF) LINE (AT THE TIME RUNNING D5NS+KCL, PREVIOUSLY RUNNING NORMAL SALINE (NS)). THE IV TUBING WAS PRIMED 2 DAYS PRIOR SO UNSURE OF LOT NUMBER, BUT IN THE SUPPLY ROOM & PRIMING ROOM THE LOT NUMBERS ARE 4949284 & 5021972. THIS IS ALL THE INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315974 | 18" (46 CM) APPX 5.1 ML, EXT SET W/0. CLAMP | IV SET, ADMINISTRATION | FPA | ICU MEDICAL INC. | CH3556 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2920 DA |