FDA Adverse Event
Injury
Summary report: N
WALKMED
MDR report key: 9950292
·
Received April 10, 2020
Report
- Report Number
- 3000204189-2020-00002
- Event Type
- Injury
- Date Received
- April 10, 2020
- Date of Event
- March 9, 2020
- Report Date
- April 10, 2020
- Manufacturer
- WALKMED, LLC
- Product Code
- FRN
- PMA / PMN Number
- K991275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHARMACIST PROGRAMMED THE PUMP FOR 20 ML/HR VERSUS 2 ML/HR. PATIENT WAS STABLE AT THE TIME OF REPORTING ((B)(6) 2020). UPON REQUEST, AFTER WALKMED EMAILED THE PHARMACIST, THEY WERE GIVEN THE INSTRUCTIONS ON PROPER PROCEDURE OF MOVING THE DECIMAL IN THE PROGRAMMING SETTINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414130 | WALKMED | WALKMED 350 VL | FRN | WALKMED, LLC | 350VL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |