FDA Adverse Event
Malfunction
Summary report: N
HORIZON MODULAR INFUSION SYSTEM
MDR report key: 269949
·
Received March 15, 2000
Report
- Report Number
- 1641965-2000-00004
- Event Type
- Malfunction
- Date Received
- March 15, 2000
- Date of Event
- February 5, 2000
- Report Date
- February 17, 2000
- Manufacturer
- B.BRAUN MEDICAL INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEVICE WAS REPORTED TO HAVE BEEN INVOLVED IN AN OVERINFUSION INCIDENT. THE PUMP WAS BEING USED FOR AN EPIDURAL INFUSION AND INFUSED 100 ML OF MEDICATION IN 2 1/2 HOURS INSTEAD OF 12 HOURS. PT WAS SENT TO ICU FOR OBSERVATION AND SUSTAINED NO SERIOUS INJURY.
Description of Event or Problem · 1
DEVICE WAS REPORTED TO HAVE BEEN INVOLVED IN AN OVERINFUSION INCIDENT. THE PUMP WAS BEING USED FOR AN EPIDURAL INFUSION AND INFUSED 100 ML OF MEDICATION IN 2 1/2 HOURS INSTEAD OF 12 HOURS. PT WAS SENT TO ICU FOR OBSERVATION AND SUSTAINED NO SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON MODULAR INFUSION SYSTEM | INFUSION PUMP | FRN | B.BRAUN MEDICAL INC. | HORIZON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization |