FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 13087080
·
Received December 27, 2021
Report
- Report Number
- 2016493-2021-77780
- Event Type
- Malfunction
- Date Received
- December 27, 2021
- Date of Event
- December 7, 2021
- Report Date
- February 2, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- 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
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. NO PRODUCT WILL BE RETURNED.
Additional Manufacturer Narrative · 0
OMIT: A140502 - FREE OR UNRESTRICTED FLOW (2945).
Description of Event or Problem · 0
IT WAS REPORTED A FREE FLOW OF INSULIN EVENT OCCURRED. THERE WAS PATIENT INVOLVEMENT BUT THE IMPACT IS UNKNOWN.
Description of Event or Problem · 0
IT WAS REPORTED A FREE FLOW OF INSULIN EVENT OCCURRED. THERE WAS PATIENT INVOLVEMENT BUT THE IMPACT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986517 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 8015 |