FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 12201470
·
Received July 21, 2021
Report
- Report Number
- 2016493-2021-55985
- Event Type
- Malfunction
- Date Received
- July 21, 2021
- Date of Event
- July 1, 2021
- Report Date
- May 18, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION TO REMOVE THE FOLLOWING CODES IN SECTION H6 REPORTED IN ERROR IN THE INITIAL MDR: ANNEX A: A070803, ANNEX G: G07001, ANNEX B: B17, ANNEX C: C20, ANNEX D: D15.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE WOULD NOT TURN ON/OFF. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative · 1
THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. RETURNED TO MANUFACTURING FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT TURN ON/OFF. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099067 | ALARIS SYSTEM | INFUSION PUMP | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |