FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 16901229
·
Received May 10, 2023
Report
- Report Number
- 2016493-2023-159775
- Event Type
- Malfunction
- Date Received
- May 10, 2023
- Date of Event
- April 17, 2023
- Report Date
- June 7, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2909-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT. 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. SEE MANUFACTURER NARRATIVE.
Additional Manufacturer Narrative · 0
ANNEX B: B21; ANNEX C: C21; ANNEX D: D16. ANNEX A: A070504; ANNEX B: B01; ANNEX C: C070606, C0601; ANNEX D: D01, D02; ANNEX G: G02002.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN 8015 PCU WAS AFFECTED BY KEYPAD RECALL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN 8015 PCU WAS AFFECTED BY KEYPAD RECALL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579820 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |