FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 12769195
·
Received November 8, 2021
Report
- Report Number
- 2016493-2021-69572
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 19, 2021
- Report Date
- November 22, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2822-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: IMDRF ANNEX A,G, B, C AND D GRIDS OMIT: A090202 - DISPLAY DIFFICULT TO READ (1181), G05005 - LED (LIGHT EMITTING DIODE), B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C16 - MANUFACTURING PROCESS PROBLEM IDENTIFIED, D03 - CAUSE TRACED TO MANUFACTURING, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION.
Additional Manufacturer Narrative · 0
PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD DIM SEG. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD DIM SEG. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1668314 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |