FDA Adverse Event
Malfunction
Summary report: N
HORIZON NXT
MDR report key: 1881286
·
Received October 6, 2010
Report
- Report Number
- 1641965-2010-00076
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Report Date
- September 7, 2010
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FRN
- PMA / PMN Number
- K904518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE EVAL FOR THE DEVICE IS UNDERWAY. BASED ON THE HISTORY OF THE DEVICE, THE DEVICE HAS NOT BEEN INSPECTED BY THE MFR IN THE LAST SIX YEARS. ADD'L INFO WILL BE PROVIDED AFTER THE EVAL IS COMPLETED.
Description of Event or Problem · 1
PUMP WAS NOT DELIVERING THE CORRECT RATE/VOLUME. PUMP WAS BEING USED ON A PT AT THE TIME. PT STATUS IS UNK. TYPE OF DRUG BEING USED IS UNK. RATE AND VOLUME IS UNK. BIOMED STATED THAT THE DEVICE WAS NOT RUNNING FOR VERY LONG BEFORE IT WAS DETECTED; HOWEVER, HE DID NOT HAVE AN EXACT TIME. THE PUMP WAS TAKEN OUT OF USE AND AN IN-HOUSE PIR WAS ISSUED. THE TUBING WAS IN SAVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON NXT | INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |