FDA Adverse Event
Other
Summary report: N
HORIZON NXT
MDR report key: 420452
·
Received October 3, 2002
Report
- Report Number
- 1641965-2002-00022
- Event Type
- Other
- Date Received
- October 3, 2002
- Date of Event
- August 1, 2002
- Report Date
- September 13, 2002
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE BIOMEDICAL TECHNICIAN FROM THE USER FACILITY CALLED TO RETURN THE DEVICE FOR SERVICE REPAIR FOR AN UNRELATED PROBLEM. WHEN TALKING WITH THE CUSTOMER SERVICE REPRESENTATIVE, THE BIOMED MENTIONED THAT THIS PUMP HAD INFUSED 400CC RATHER THAN THE INTENDED 100 CC DURING A PATIENT INFUSION. WHEN FURTHER INFORMATION WAS REQUESTED, THE REPORTER STATED THEY COULD NOT GIVE ANY INFORMATION ABOUT THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON NXT | MODULAR INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |